The DOI matches its Crossref record; 32 of the 32 references it cites were found in a registry or an index; 25 of the 48 sources its claims cite were checked for support.
Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer.
Open accessAbstract
BACKGROUND: In a previous analysis of this phase 3 trial, first-line ribociclib plus letrozole resulted in significantly longer progression-free survival than letrozole alone among postmenopausal patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Whether overall survival would also be longer with ribociclib was not known. METHODS: Here we report the results of the protocol-specified final analysis of overall survival, a key secondary end point. Patients were randomly assigned in a 1:1 ratio to receive either ribociclib or placebo in combination with letrozole. Overall survival was assessed with the use of a stratified log-rank test and summarized with the use of Kaplan-Meier methods after 400 deaths had occurred. A hierarchical testing strategy was used for the analysis of progression-free survival and overall survival to ensure the validity of the findings. RESULTS: After a median follow-up of 6.6 years, 181 deaths had occurred among 334 patients (54.2%) in the ribociclib group and 219 among 334 (65.6%) in the placebo group. Ribociclib plus letrozole showed a significant overall survival benefit as compared with placebo plus letrozole. Median overall survival was 63.9 months (95% confidence interval [CI], 52.4 to 71.0) with ribociclib plus letrozole and 51.4 months (95% CI, 47.2 to 59.7) with placebo plus letrozole (hazard ratio for death, 0.76; 95% CI, 0.63 to 0.93; two-sided P = 0.008). No new safety signals were observed. CONCLUSIONS: First-line therapy with ribociclib plus letrozole showed a significant overall survival benefit as compared with placebo plus letrozole in patients with HR-positive, HER2-negative advanced breast cancer. Median overall survival was more than 12 months longer with ribociclib than with placebo. (Funded by Novartis; MONALEESA-2 ClinicalTrials.gov number, NCT01958021.).
Overview
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
25 of 48 cited sources checked · 7 supported · 7 flagged · accuracy not yet measured
At least one cited source doesn’t support this claim or points to a different paper, and none confirmed it — see the verdicts below.
In the paper
“This trial has a long follow-up (median, 80 months). 19-23”
What the sources say
- Disputedcites [19] 19. Johnston S, Martin M, Di Leo A, et al. MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. NPJ Breast Cancer 2019; 5: 5. sourceExperimental — accuracy not yet measured
The Results > Efficacy passage reports a median follow-up of 26.73 months at the final data cutoff, not 80 months. This directly contradicts the follow-up duration attributed to this trial. (LLM, conf=0.93)
Checked by a reasoning model — may be wrong.
- Disputedcites [20] 20. Slamon DJ, Neven P, Chia S, et al. Ribociclib plus fulvestrant for postmenopausal women with hormone receptorpositive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival. Ann Oncol 2021; 32: 1015-24. sourceExperimental — accuracy not yet measured
The Discussion (pp. 7, 9) calls this an extended, long follow-up analysis, but gives the median follow-up as 56.3 months, not 80 months. The stated duration directly contradicts the claim's figure. (LLM, conf=0.92)
Checked by a reasoning model — may be wrong.
- Disputedcites [21] 21. Rugo HS, Finn RS, Diéras V, et al. Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up. Breast Cancer Res Treat 2019; 174: 719-29. sourceExperimental — accuracy not yet measured
The Efficacy section reports median follow-up of 37.6 months in the palbociclib–letrozole arm and 37.3 months in the placebo–letrozole arm, not 80 months. The Discussion calls the follow-up long relative to other phase 3 CDK4/6 inhibitor studies, but does not support the claimed duration. (LLM, conf=0.90)
Checked by a reasoning model — may be wrong.
- Not checked — no full text of the sourcecites [22] 22. Tripathy D, Im S-A, Colleoni M, et al. Updated overall survival (OS) results from the phase III MONALEESA-7 trial of preor perimenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib. Cancer Res 2021; 81: Suppl 4: PD2-04. abstract. source
- Not checked — no full text of the sourcecites [23] 23. Cristofanilli M, Rugo HS, Im S-A, et al. Overall survival (OS) with palbociclib (PAL) + fulvestrant (FUL) in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC): updated analyses from PALOMA-3. J Clin Oncol 2021; 39: Suppl 15: 1000. abstract. source
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passes- Disputed
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Data for overall survival were immature at the time of the primary and updated analyses.”
What the sources say
- Partly supportedcites [10] 10. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med 2016; 375: 1738-48. sourceExperimental — accuracy not yet measured
The Characteristic section states that overall survival results were not mature at the interim analysis, supporting the claim about the primary analysis. This 2016 paper does not report an updated analysis or establish whether overall survival data were still immature then. (LLM, conf=0.87)
- Not checked — no full text of the sourcecites [17] 17. Hortobagyi GN, Stemmer SM, Burris HA, et al. Updated results from MONALEESA-2, a phase III trial of firstline ribociclib plus letrozole versus place- n engl j med 386;10 nejm.org March 10, 2022 bo plus letrozole in hormone receptorpositive, HER2-negative advanced breast cancer. Ann Oncol 2018; 29: 1541-7. source
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes- Partly supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“To date, two trials evaluating ribociclib that included some patients receiving firstline therapy showed a significant overall survival benefit. 14-16”
What the sources say
- Not checked — no full text of the sourcecites [14] 14. Im S-A, Lu Y-S, Bardia A, et al. Overall survival with ribociclib plus endocrine therapy in breast cancer. N Engl J Med 2019; 381: 307-16. source
- Partly supportedcites [15] 15. Slamon DJ, Neven P, Chia S, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med 2020; 382: 514-24. sourceExperimental — accuracy not yet measured
The Discussion (page unavailable) says that MONALEESA-3 and MONALEESA-7 both showed significant overall-survival benefits. The Overall Survival section documents patients receiving first-line treatment in MONALEESA-3, but our copy does not establish that MONALEESA-7 also enrolled first-line patients. (LLM, conf=0.82)
- Partly supportedcites [16] 16. Sledge GW Jr, Toi M, Neven P, et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptorpositive, ERBB2-negative breast cancer that progressed on endocrine therapy MONARCH 2: a randomized clinical trial. JAMA Oncol 2020; 6: 116-24. sourceExperimental — accuracy not yet measured
The Discussion (page not available) reports a statistically significant overall-survival improvement in one ribociclib trial, MONALEESA-7. The paper does not report significant overall-survival benefits for two ribociclib trials or establish that the trial it discusses included patients receiving first-line therapy; the References list MONALEESA-2 as a first-line trial but give no survival result for it. (LLM, conf=0.86)
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesThe cited sources support only part of this claim — read each source’s verdict below.
In the paper
“In the primary and updated analyses of MONALEESA-2, progression-free survival was significantly longer with ribociclib plus letrozole than with placebo plus letrozole (median in updated analysis, 25.3 months vs. 16.0 months; hazard ratio for disease progression or death, 0.57; 95% confidence interval [CI], 0.46 to 0.70; P<0.001).”
What the sources say
- Partly supportedcites [10] 10. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med 2016; 375: 1738-48. sourceExperimental — accuracy not yet measured
The Efficacy of Ribociclib plus Letrozole section reports significantly longer progression-free survival with ribociclib plus letrozole in the primary interim analysis. It gives a hazard ratio of 0.56 (95% CI, 0.43 to 0.72), not the claimed 0.57 (95% CI, 0.46 to 0.70); our copy does not report the cited updated-analysis figures. (LLM, conf=0.88)
- Not checked — no full text of the sourcecites [17] 17. Hortobagyi GN, Stemmer SM, Burris HA, et al. Updated results from MONALEESA-2, a phase III trial of firstline ribociclib plus letrozole versus place- n engl j med 386;10 nejm.org March 10, 2022 bo plus letrozole in hormone receptorpositive, HER2-negative advanced breast cancer. Ann Oncol 2018; 29: 1541-7. source
Strength:plain· not yet calibratedCausal:correlational· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passes- Partly supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“In the primary and updated analyses of MONALEESA-2, progression-free survival was significantly longer with ribociclib plus letrozole than with placebo plus letrozole (median in updated analysis, 25.3 months vs. 16.0 months; hazard ratio for disease progression or death, 0.57; 95% confidence interval [CI], 0.46 to 0.70; P<0.001).”
What the sources say
- Partly supportedcites [10] 10. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med 2016; 375: 1738-48. sourceExperimental — accuracy not yet measured
The Efficacy of Ribociclib plus Letrozole section reports significantly longer progression-free survival with ribociclib plus letrozole at the interim analysis. It does not report the claimed updated-analysis medians of 25.3 and 16.0 months; instead, the ribociclib median had not been reached and the placebo median was 14.7 months. No page numbers are available in our copy. (LLM, conf=0.90)
- Not checked — no full text of the sourcecites [17] 17. Hortobagyi GN, Stemmer SM, Burris HA, et al. Updated results from MONALEESA-2, a phase III trial of firstline ribociclib plus letrozole versus place- n engl j med 386;10 nejm.org March 10, 2022 bo plus letrozole in hormone receptorpositive, HER2-negative advanced breast cancer. Ann Oncol 2018; 29: 1541-7. source
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passes- Partly supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“In addition, the MONALEESA-3 trial showed significantly longer overall survival among postmenopausal patients with first- and second-line ribociclib plus fulvestrant than with fulvestrant alone. 15”
What the sources say
- Supportedcites [15] 15. Slamon DJ, Neven P, Chia S, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med 2020; 382: 514-24. source
The Abstract reports that MONALEESA-3 compared ribociclib plus fulvestrant with placebo plus fulvestrant as first- or second-line treatment and found a significant overall survival benefit. It describes the trial population as postmenopausal patients with advanced breast cancer. (LLM, conf=0.94)
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes- Supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Increased expression of CDK4 has been shown to drive resistance to endocrine therapy in patients with HR-positive breast cancer. 4-7”
What the sources say
- Not checked — no full text of the sourcecites [4] 4. Hosford SR, Miller TW. Clinical potential of novel therapeutic targets in breast cancer: CDK4/6, Src, JAK/STAT, PARP, HDAC, and PI3K/AKT/mTOR pathways. Pharmgenomics Pers Med 2014; 7: 203-15.
- Partly supportedcites [5] 5. Thangavel C, Dean JL, Ertel A, et al. Therapeutically activating RB: reestablishing cell cycle control in endocrine therapyresistant breast cancer. Endocr Relat Cancer 2011; 18: 333-45. sourceExperimental — accuracy not yet measured
The Results section on RB activation reports that blocking CDK4/6 curtailed cell-cycle progression in endocrine therapy-resistant breast cancer models. The Discussion links resistance to sustained cyclin D1–dependent kinase activity, but the paper does not show that increased CDK4 expression drives resistance in HR-positive patients. Its mechanistic evidence comes primarily from models, not a patient-level test of that claim. (LLM, conf=0.86)
- Not checked — no full text of the sourcecites [6] 6. Shapiro GI. Cyclin-dependent kinase pathways as targets for cancer treatment. J Clin Oncol 2006; 24: 1770-83. source
- Partly supportedcites [7] 7. Miller TW, Balko JM, Fox EM, et al. ERα-dependent E2F transcription can mediate resistance to estrogen deprivation in human breast cancer. Cancer Discov 2011; 1: 338-51. sourceExperimental — accuracy not yet measured
The Results section on CDK4 reports that CDK4 knockdown or CDK4/6 inhibition suppressed hormone-independent growth in ER-positive breast cancer cell lines. The patient-tumor findings instead link an E2F activation signature—not higher CDK4 expression—to poorer response to aromatase inhibitors. The paper therefore supports a role for CDK4 in a resistance-related pathway, but does not show that increased CDK4 expression drives endocrine resistance in patients. (LLM, conf=0.88)
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesThe sources with a verdict support this claim; the rest weren’t checked yet, have no full text we could read, or their verdicts aren’t rated yet.
In the paper
“In a previous analysis of this phase 3 trial, first-line ribociclib plus letrozole resulted in significantly longer progression-free survival than letrozole alone among postmenopausal patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer.”
- Also stated in: § ABSTRACT · p. 3 · plain
“In the primary and updated analyses of MONALEESA-2, progression-free survival was significantly longer with ribociclib plus letrozole than with placebo plus letrozole (median in updated analysis, 25.3 months vs. 16.0 months; hazard ratio for disease progression or death, 0.57; 95% confidence interval [CI], 0.46 to 0.70; P<0.001).”
What the sources say
- Supportedcites [10] 10. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med 2016; 375: 1738-48. source
The Methods identify this as a phase 3 first-line trial in postmenopausal women with HR-positive, HER2-negative advanced breast cancer. The Discussion reports that, at the planned interim analysis, progression-free survival was significantly longer with ribociclib plus letrozole than with placebo plus letrozole. The claim's “letrozole alone” describes that placebo-plus-letrozole comparator. (LLM, conf=0.95)
- Not checked — no full text of the sourcecites [17] 17. Hortobagyi GN, Stemmer SM, Burris HA, et al. Updated results from MONALEESA-2, a phase III trial of firstline ribociclib plus letrozole versus place- n engl j med 386;10 nejm.org March 10, 2022 bo plus letrozole in hormone receptorpositive, HER2-negative advanced breast cancer. Ann Oncol 2018; 29: 1541-7. source
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes- Also stated in: § ABSTRACT · p. 3 · plain
The sources with a verdict support this claim; the rest weren’t checked yet, have no full text we could read, or their verdicts aren’t rated yet.
In the paper
“These trials showed a 29%, 28%, and 24% lower risk of death, respectively.”
What the sources say
- Not checked — no full text of the sourcecites [14] 14. Im S-A, Lu Y-S, Bardia A, et al. Overall survival with ribociclib plus endocrine therapy in breast cancer. N Engl J Med 2019; 381: 307-16. source
- Supportedcites [15] 15. Slamon DJ, Neven P, Chia S, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med 2020; 382: 514-24. source
The Overall Survival section reports a 28% lower relative risk of death for ribociclib plus fulvestrant than for placebo plus fulvestrant (hazard ratio 0.72). The paper also reports hazard ratios of 0.71 and 0.76 for the other trials, corresponding to the cited 29% and 24% reductions, respectively. (LLM, conf=0.92)
- Supportedcites [16] 16. Sledge GW Jr, Toi M, Neven P, et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptorpositive, ERBB2-negative breast cancer that progressed on endocrine therapy MONARCH 2: a randomized clinical trial. JAMA Oncol 2020; 6: 116-24. source
The Overall Survival section reports a hazard ratio of 0.757 for abemaciclib plus fulvestrant versus placebo plus fulvestrant, equivalent to approximately 24% lower risk of death. This supports the 24% figure attributed to MONARCH 2; this source is not being used to substantiate the other two trials’ figures. (LLM, conf=0.93)
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesThe sources with a verdict support this claim; the rest weren’t checked yet, have no full text we could read, or their verdicts aren’t rated yet.
In the paper
“Previously, the MONALEESA-7, MONALEESA-3, and MONARCH 2 trials have shown a significant overall survival benefit with the addition of a CDK4/6 inhibitor (either ribociclib or abemaciclib) in broad groups of patients with HR-positive, HER2-negative advanced breast cancer. 14-16”
What the sources say
- Not checked — no full text of the sourcecites [14] 14. Im S-A, Lu Y-S, Bardia A, et al. Overall survival with ribociclib plus endocrine therapy in breast cancer. N Engl J Med 2019; 381: 307-16. source
- Supportedcites [15] 15. Slamon DJ, Neven P, Chia S, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med 2020; 382: 514-24. source
The Discussion reports significant overall-survival benefits in MONALEESA-3 and MONALEESA-7 with ribociclib and in MONARCH 2 with abemaciclib. It identifies these as trials involving patients with hormone-receptor-positive, HER2-negative advanced breast cancer, while noting that the trial populations differed. (LLM, conf=0.93)
- Supportedcites [16] 16. Sledge GW Jr, Toi M, Neven P, et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptorpositive, ERBB2-negative breast cancer that progressed on endocrine therapy MONARCH 2: a randomized clinical trial. JAMA Oncol 2020; 6: 116-24. source
The Key Points report that MONARCH 2 found significantly improved overall survival with abemaciclib plus fulvestrant versus placebo plus fulvestrant in patients with HR-positive, ERBB2-negative advanced breast cancer. The Discussion also calls the improvement statistically significant. This source supports the MONARCH 2 portion of the multi-trial claim; its participants had progressed on prior endocrine therapy. (LLM, conf=0.93)
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes
- The quote only partly states this claim. 3
- It may state two separate claims as one. 18
- Probably not a substantial claim. 16
At least one cited source doesn’t support this claim or points to a different paper, and none confirmed it — see the verdicts below.
In the paper
“as well as impressive median survival to date (63.9 months) among women with HR-positive, HER2-negative advanced breast cancer. 16,20,22-29”
What the sources say
- Disputedcites [16] 16. Sledge GW Jr, Toi M, Neven P, et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptorpositive, ERBB2-negative breast cancer that progressed on endocrine therapy MONARCH 2: a randomized clinical trial. JAMA Oncol 2020; 6: 116-24. sourceExperimental — accuracy not yet measured
The Overall Survival section reports a median of 46.7 months for abemaciclib plus fulvestrant, not 63.9 months for ribociclib. The Discussion mentions ribociclib only in connection with a separate study’s survival hazard ratio; it gives no ribociclib median survival of 63.9 months. Page numbers are unavailable in our copy. (LLM, conf=0.88)
Checked by a reasoning model — may be wrong.
- Disputedcites [20] 20. Slamon DJ, Neven P, Chia S, et al. Ribociclib plus fulvestrant for postmenopausal women with hormone receptorpositive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival. Ann Oncol 2021; 32: 1015-24. sourceExperimental — accuracy not yet measured
The Overall survival section (p. 3) reports median overall survival of 53.7 months in the ribociclib arm, not 63.9 months, at the October 2020 data cutoff. The Results summary (p. 1) gives the same 53.7-month figure. (LLM, conf=0.90)
Checked by a reasoning model — may be wrong.
- Not checked — no full text of the sourcecites [22] 22. Tripathy D, Im S-A, Colleoni M, et al. Updated overall survival (OS) results from the phase III MONALEESA-7 trial of preor perimenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib. Cancer Res 2021; 81: Suppl 4: PD2-04. abstract. source
- Not checked — no full text of the sourcecites [23] 23. Cristofanilli M, Rugo HS, Im S-A, et al. Overall survival (OS) with palbociclib (PAL) + fulvestrant (FUL) in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC): updated analyses from PALOMA-3. J Clin Oncol 2021; 39: Suppl 15: 1000. abstract. source
- Not checked — no full text of the sourcecites [24] 24. Bergh J, Jönsson P-E, Lidbrink EK, et al. FACT: an open-label randomized phase III study of fulvestrant and anastrozole in combination compared with anastrozole alone as first-line therapy for patients with receptor-positive postmenopausal breast cancer. J Clin Oncol 2012; 30: 1919-25. source
- Disputedcites [25] 25. Johnston SR, Kilburn LS, Ellis P, et al. Fulvestrant plus anastrozole or placebo versus exemestane alone after progression on non-steroidal aromatase inhibitors in postmenopausal patients with hormonereceptor-positive locally advanced or metastatic breast cancer (SoFEA): a composite, multicentre, phase 3 randomised trial. Lancet Oncol 2013; 14: 989-98. sourceExperimental — accuracy not yet measured
The overall-survival figure in the Interpretation section (page unavailable) reports medians of 20.2, 19.4, and 21.6 months for the fulvestrant/anastrozole, fulvestrant/placebo, and exemestane groups, respectively. This trial had no ribociclib group and does not report a 63.9-month median survival for its patients. (LLM, conf=0.86)
Checked by a reasoning model — may be wrong.
- Not checked — no full text of the sourcecites [26] 26. Piccart M, Hortobagyi GN, Campone M, et al. Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2. Ann Oncol 2014; 25: 2357-62. source
- Could not verifycites [27] 27. Ellis MJ, Llombart-Cussac A, Feltl D, et al. Fulvestrant 500 mg versus anastrozole 1 mg for the first-line treatment of advanced breast cancer: overall survival analysis from the phase II FIRST study. J Clin Oncol 2015; 33: 3781-7. sourceExperimental — accuracy not yet measured
The Results > Efficacy section reports median overall survival of 54.1 months with fulvestrant and 48.4 months with anastrozole, not a ribociclib outcome. A search for ribociclib and 63.9 months found no passage addressing the claimed survival figure; the paper's different treatment comparison does not establish a contrary ribociclib result. (LLM, conf=0.78)
- Not checked — no full text of the sourcecites [28] 28. Mehta RS, Barlow WE, Albain KS, et al. Overall survival with fulvestrant plus anastrozole in metastatic breast cancer. N Engl J Med 2019; 380: 1226-34. source
- Disputedcites [29] 29. André F, Ciruelos EM, Juric D, et al. Alpelisib plus fulvestrant for PIK3CAmutated, hormone receptor-positive, human epidermal growth factor receptor2-negative advanced breast cancer: final overall survival results from SOLAR-1. Ann Oncol 2021; 32: 208-17. sourceExperimental — accuracy not yet measured
The Overall Survival section (page unavailable) reports median survival of 39.3 months with alpelisib plus fulvestrant and 31.4 months with placebo plus fulvestrant, not 63.9 months in a ribociclib group. Ribociclib studies appear in the References, but this paper does not report the claimed result. (LLM, conf=0.87)
Checked by a reasoning model — may be wrong.
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesThe quote only partly states this claim.
- Disputed
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“The use of CDK4/6 inhibitors (ribociclib, abemaciclib, and palbociclib) improved progression-free survival in this patient population, leading to regulatory approvals. 9-13”
What the sources say
- Not checked — no full text of the sourcecites [9] 9. Cristofanilli M, Turner NC, Bondarenko I, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol 2016; 17: 425-39. source
- Partly supportedcites [10] 10. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med 2016; 375: 1738-48. sourceExperimental — accuracy not yet measured
The Results and Discussion report significantly longer progression-free survival with ribociclib plus letrozole than with placebo plus letrozole in postmenopausal women with HR-positive, HER2-negative advanced breast cancer. The paper describes CDK4/6 inhibition more broadly and cites palbociclib studies, but it does not establish a progression-free-survival benefit for abemaciclib or say that these findings led to regulatory approvals. (LLM, conf=0.88)
- Not checked — no full text of the sourcecites [11] 11. Goetz MP, Toi M, Campone M, et al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol 2017; 35: 3638-46. source
- Partly supportedcites [12] 12. Cardoso F, Paluch-Shimon S, Senkus E, et al. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5). Ann Oncol 2020; 31: 1623-49. sourceExperimental — accuracy not yet measured
In the guideline discussion following Methodology (page unavailable), the panel describes CDK4/6 inhibitors as beneficial for ER-positive/HER2-negative advanced breast cancer and recommends combining them with endocrine therapy. The passages found do not specifically document improved progression-free survival for all three named drugs or say that those results led to regulatory approvals. (LLM, conf=0.77)
- Not matchedcites [13] 13. National Comprehensive Cancer Network. Metastatic breast cancer. 2020 (https://www . nccn . org/ patients/ guidelines/ content/ PDF/ stage\_iv\_breast - patient . pdf).
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“The median duration of exposure to trial treatment in the ribociclib group was 20.2 months (interquartile range, 7.4 to 45.1), which is 7 months longer than it was at the time of the primary analysis of progression-free survival. 10”
What the sources say
- Partly supportedcites [10] 10. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med 2016; 375: 1738-48. sourceExperimental — accuracy not yet measured
The Treatment section reports 13.0 months as the ribociclib group's median treatment exposure at the January 2016 cutoff, supporting the claim's reference to the earlier analysis. It does not report the later 20.2-month median, the 7.4–45.1-month interquartile range, or the increase to that later value. Page number is unavailable in our copy. (LLM, conf=0.86)
Strength:plain· not yet calibratedn = 334Tests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
- Partly supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“The PALOMA-3 trial showed a 19% lower risk of death, which was”
- Also stated in: § Discussion · p. 9 · plain
“not considered to be significant. 30”
What the sources say
- Supportedcites [30] 30. Turner NC, Slamon DJ, Ro J, et al. Overall survival with palbociclib and fulvestrant in advanced breast cancer. N Engl J Med 2018; 379: 1926-36. Copyright © 2022 Massachusetts Medical Society. source
The overall-survival figure (p. 1930) reports a stratified hazard ratio for death of 0.81, corresponding to a 19% lower estimated risk, with P=0.09. The Discussion also says the overall-survival finding did not reach significance in the intention-to-treat population. (LLM, conf=0.94)
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one. The quote only partly states this claim.
- Also stated in: § Discussion · p. 9 · plain
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The median duration of exposure to placebo was 14.1 months (interquartile range, 7.1 to 28.9).”
Strength:plain· not yet calibratedn = 334Tests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Unfortunately, only 2.5% of women in the trial were Black; thus, this demographic group was underrepresented in our trial.”
Strength:plain· not yet calibratedn = 334Tests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Among all patients, the median duration of follow-up (randomization to data cutoff) was 80 months (minimum, 75 months).”
Strength:plain· not yet calibratedn = 334Tests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“At the data cutoff date for this final analysis of overall survival, 30 of 334 patients (9.0%) in the ribociclib group and 17 of 334 patients (5.1%) in the placebo group were still receiving ribociclib plus letrozole or placebo plus letrozole as assigned.”
Strength:plain· not yet calibratedn = 334Tests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The Kaplan-Meier analysis shows that the overall survival benefit of ribociclib began to emerge at approximately 20 months and continued to increase with longer follow-up, as indicated by survival at 5 years and 6 years.”
Strength:hedged· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The overall survival benefit with ribociclib in these subgroups was consistent with the results in the overall population; however, the small number of patients in some subgroups resulted in wide confidence intervals.”
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“After adjustment for the subsequent treatment with a CDK4/6 inhibitor, the median overall survival in the placebo group was estimated to be 50.5 months (95% CI, 45.0 to 55.4), as compared with 51.4 months (95% CI, 47.2 to 59.7) in the main analysis (hazard ratio for death, 0.73; 95% CI, 0.58 to 0.92).”
Load-bearingStrength:hedged· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Additional key grade 3 or 4 adverse events of special interest in the ribociclib and placebo groups were hepatobiliary toxic effects (14.4% and 4.8%, respectively) and prolonged QT interval (4.5% and 2.1%, respectively).”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“No grade 4 adverse events or deaths related to interstitial lung disease or pneumonitis occurred in the ribociclib group.”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Among the patients who discontinued the trial regimen, subsequent antineoplastic therapies were received by 267 of 304 patients (87.8%) in the ribociclib group and 286 of 317 patients (90.2%) in the placebo group (Tables 2 and S3).”
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
In the paper
“The rankpreserving structural failure time (RPSFT) model was used in a sensitivity analysis of overall survival to assess the effects of subsequent administration of CDK4/6 inhibitors in the placebo group after discontinuation of the trial regimen. 18”
What the sources say
- Not checked — no full text of the sourcecites [18] 18. Robins JM, Tsiatis AA. Correcting for non-compliance in randomized trials using rank preserving structural failure time models. Commun Stat Theory Methods 1991; 20: 2609-31. source
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Overall survival was to be tested under a five-look group sequential design only if progression-free survival results reached statistical significance according to the prespecified conditions in the protocol.”
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“All the investigators who administered ribociclib or placebo, analyzed data, and assessed outcomes, as well as all the patients, were unaware of the trial-group assignments.”
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim. It may state two separate claims as one.
In the paper
“Preclinically, ribociclib has been shown to inhibit CDK4 preferentially and has also shown high drug concentrations at clinically relevant doses. 8”
What the sources say
- Not checked — no full text of the sourcecites [8] 8. Chen P, Lee NV, Hu W, et al. Spectrum and degree of CDK drug interactions predicts clinical performance. Mol Cancer Ther 2016; 15: 2273-81. source
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“A hierarchical testing strategy between progression-free survival and overall survival was used to control the familywise type I error rate at 2.5% and supported the validity of the findings.”
- Also stated in: § METHODS · p. 2 · plain
“A hierarchical testing strategy was used for the analysis of progression-free survival and overall survival to ensure the validity of the findings.”
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
- Also stated in: § METHODS · p. 2 · plain
In the paper
“Cyclin-dependent kinases 4 and 6 (CDK4/6) play a key function in regulating cell-cycle progression and have a known role in promoting growth in cancer. 3”
What the sources say
- Not checked — no full text of the sourcecites [3] 3. O'Leary B, Finn RS, Turner NC. Treating cancer with selective CDK4/6 inhibitors. Nat Rev Clin Oncol 2016; 13: 417-30. source
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Crossover between the two groups was not allowed until the final analysis of overall survival was completed.”
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Four patients assigned to the placebo group did not receive placebo plus letrozole as assigned.”
Strength:plain· not yet calibratedn = 4Tests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Randomization was stratified according to the presence or absence of liver or lung metastases.”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“An independent data monitoring committee assessed safety data.”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Patients were randomly assigned in a 1:1 ratio to receive either ribociclib (600 mg per day, administered orally once daily for 21 consecutive days, followed by 7 days off, for a complete cycle of 28 days) or a matching placebo. Patients in both groups received letrozole (2.5 mg per day on a continuous schedule).”
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Before enrollment, all the patients provided written informed consent.”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The trial protocol and all amendments (available with the full text of this article at NEJM.org) were approved by the institutional review board at each site or by an independent ethics committee.”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“This trial was conducted in accordance with the provisions of the Declaration of Helsinki and Good Clinical Practice guidelines and was funded by Novartis.”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“the ribociclib group had a significant overall survival benefit.”
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one. The quote only partly states this claim.
The paper relies on this without support.
The trial population is representative of the broader population of postmenopausal patients with HR-positive, HER2-negative advanced breast cancer.
“Epidemiologic data explicitly for patients with HR-positive, HER2-negative metastatic breast cancer are quite limited; however, the patients in this trial were representative of patients with breast cancer overall with respect to sex and age (Table S2).”
“Unfortunately, only 2.5% of women in the trial were Black; thus, this demographic group was underrepresented in our trial.”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“no numerical effect was observed in patients with liver metastases with the addition of ribociclib to letrozole in MONALEESA-2.19”
From Abemaciclib plus a nonsteroidal aromatase inhibitor as initial therapy for HR+, HER2- advanced breast cancer: final overall survival results of MONARCH 3. (2024) · cites this paper as [19]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“In the MONALEESA-2 trial (n ¼ 668; 1 : 1 randomization; 6.6 years median follow-up), the addition of ribociclib versus placebo to letrozole demonstrated a significant improvement in OS, with a median OS increase of 12.5 months (median OS 63.9 versus 51.4 months).19”
From Abemaciclib plus a nonsteroidal aromatase inhibitor as initial therapy for HR+, HER2- advanced breast cancer: final overall survival results of MONARCH 3. (2024) · cites this paper as [19]
The cited source says what the claim attributes to it.
In the citing paper
“the 13.1-month increase in median OS (median OS 66.8 versus 53.7 months) was comparable with the 12.5-month improvement in median OS observed in the MONALEESA-2 trial.”
From Abemaciclib plus a nonsteroidal aromatase inhibitor as initial therapy for HR+, HER2- advanced breast cancer: final overall survival results of MONARCH 3. (2024) · cites this paper as [19]
The cited source says what the claim attributes to it.
In the citing paper
“This is the third pivotal trial to demonstrate a significant improvement in OS with ribociclib in a first-line setting”
The cited source says what the claim attributes to it.
In the citing paper
“In MONALEESA-2, first-line ribociclib + letrozole in postmenopausal women demonstrated a significant 12.5-month improvement over letrozole alone, with an mOS of 63.9 versus 51.4 months (HR 0.76; 95% CI 0.63–0.93; P = 0.008) [14].”
Citations
Cites
Ribociclib as first-line therapy for HR-positive, advanced breast cancer
Hortobagyi, G. N., Stemmer, S. M., Burris, H. A., Yap, Y.-S., Sonke, G. S., Paluch-Shimon, S., Campone, M., Blackwell, K. L., André, F., Winer, E. P., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1609709 · Cited by 2,039
Self-citationCristofanilli, M., Turner, N. C., Bondarenko, I., Ro, J., Im, S.-A., Masuda, N., Colleoni, M., DeMichele, A., Loi, S., Verma, S., et al. (2016) · The Lancet Oncology · doi:10.1016/s1470-2045(15)00613-0 · Cited by 1,827
MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer
Goetz, M. P., Toi, M., Campone, M., Sohn, J., Paluch-Shimon, S., Huober, J., Park, I. H., Trédan, O., Chen, S.-C., Manso, L., et al. (2017) · Journal of Clinical Oncology · doi:10.1200/jco.2017.75.6155 · Cited by 1,744
Self-citation5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5)
Cardoso, F., Paluch-Shimon, S., Senkus, E., Curigliano, G., Aapro, M. S., André, F., Barrios, C. H., Bergh, J., Bhattacharyya, G. S., Biganzoli, L., et al. (2020) · Annals of Oncology · doi:10.1016/j.annonc.2020.09.010 · Cited by 1,369
Self-citationOverall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer
Turner, N. C., Slamon, D. J., Ro, J., Bondarenko, I., Im, S.-A., Masuda, N., Colleoni, M., DeMichele, A., Loi, S., Verma, S., et al. (2018) · New England Journal of Medicine · doi:10.1056/nejmoa1810527 · Cited by 1,276
Self-citationTreating cancer with selective CDK4/6 inhibitors
O'Leary, B., Finn, R. S., & Turner, N. C. (2016) · Nature Reviews Clinical Oncology · doi:10.1038/nrclinonc.2016.26 · Cited by 1,137
Cyclin-Dependent Kinase Pathways As Targets for Cancer Treatment
Shapiro, G. I. (2006) · Journal of Clinical Oncology · doi:10.1200/jco.2005.03.7689 · Cited by 1,036
Overall survival with ribociclib plus endocrine therapy in breast cancer
Im, S.-A., Lu, Y.-S., Bardia, A., Harbeck, N., Colleoni, M., Franke, F., Chow, L., Sohn, J., Lee, K.-S., Campos-Gomez, S., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1903765 · Cited by 1,001
Self-citationSledge, G. W., Toi, M., Neven, P., Sohn, J., Inoue, K., Pivot, X., Burdaeva, O., Okera, M., Masuda, N., Kaufman, P. A., et al. (2020) · JAMA Oncology · doi:10.1001/jamaoncol.2019.4782 · Cited by 991
Self-citationHortobagyi, G. N., Stemmer, S. M., Burris, H. A., Yap, Y. S., Sonke, G. S., Paluch-Shimon, S., Campone, M., Petrakova, K., Blackwell, K. L., Winer, E. P., et al. (2018) · Annals of Oncology · doi:10.1093/annonc/mdy155 · Cited by 876
Self-citation
Flagged first, then by citations
Cited by
Sorted by citations
Items 401–500 of 760
Schettini, F., Nucera, S., Grazia, G. D., Giudici, F., Strina, C., Milani, M., Tancredi, R. J., Conte, B., Criscitiello, C., Giuliano, M., et al. (2025) · JNCI Cancer Spectrum · doi:10.1093/jncics/pkaf083 · Cited by 2
“39 Our meta-analysis has been conducted in response to the growing body of RWE assessing the efficacy and safety of palbociclib in daily practice.”
When suboptimal post-protocol care in oncology trials is rewarded
Salfi, G., & Olivier, T. (2025) · European Journal of Cancer · doi:10.1016/j.ejca.2025.115702 · Cited by 2
Liu, Y., Wang, Y., Zhang, N., Xiong, H., Zhao, L., Qi, Y., Xie, J., Duan, X., Yue, D., & Qie, S. (2025) · Science China Life Sciences · doi:10.1007/s11427-024-3015-1 · Cited by 2
“Due to the ineffective outcome of monotherapy, a series of combined therapies has been developed, like combined treatments with inhibitors targeting EGFR, MEK, mTOR, PI3K, or with immunotherapies (Cai et al., 2023; Hortobagyi et al., 2022).”
Tappenden, P., Cooper, K. L., Hamilton, J., Nalbant, G., Essat, M., Rayner, A., Wong, R., Battisti, N. M. L., Wyld, L., & Asghar, U. S. (2025) · Health Technology Assessment · doi:10.3310/kgfd4040 · Cited by 3
Wortelboer, N., Kent, S., Blommestein, H. M., van Ommen‐Nijhof, A., van der Noort, V., van den Pol, E., Páez, C. G., Beeker, A., Beelen, K. J., Hamming, L. C., et al. (2025) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/djaf334 · Cited by 2
Self-citationRB loss sensitizes triple-negative breast cancer to apoptosis induced by cellular stress
Witkiewicz, A. K., Venkata, S. A. K., Knudsen, E. S., & Kumarasamy, V. M. (2025) · Cell Death Discovery · doi:10.1038/s41420-025-02864-4 · Cited by 2
“The development of CDK4/6 inhibitors has been a major clinical breakthrough in estrogen receptor-positive (ER + ) breast cancer patients, signi fi cantly improving overall survival when combined with endocrine therapy [11 – 14].”
Overview of ocular toxicities associated with breast cancer therapies
Greenberg, M. R., Noveihed, A., & George, M. A. (2025) · Breast Cancer Research and Treatment · doi:10.1007/s10549-025-07843-y · Cited by 2
Mazzoli, G., Provenzano, L., Dieci, M. V., Curigliano, G., Giuliano, M., Botticelli, A., Lambertini, M., Rizzo, G., Pedersini, R., Sirico, M., et al. (2025) · The Breast · doi:10.1016/j.breast.2026.104692 · Cited by 3
Houdt, M. V., Kenis, C., Nys, L., et al. (2026) · ESMO Open · doi:10.1016/j.esmoop.2025.105896 · Cited by 2
“23 This possibly reflects the difficulty many older patients face in tolerating treatment, leading to early discontinuation.”
Cottu, P. H., Kieffer, Y., Lemonnier, J., D’Hondt, V., Duhoux, F. P., Callens, C., Gentien, D., Réyès, C., Boulai, A., Desmoulins, I., et al. (2026) · Cell Reports Medicine · doi:10.1016/j.xcrm.2025.102544 · Cited by 2
“3,8 Furthermore, ROR demonstrated superior performance as a prognostic indicator following neoadjuvant therapy in patients with LBC, either endocrine therapy-CDK4/6i combination or CT.”
Martín-Quesada, A. I., & Martín-Abreu, C. M. (2026) · Seminars in Oncology · doi:10.1016/j.seminoncol.2026.152466 · Cited by 3
Characterization of ESR1 alterations in patients with breast and gynecologic cancers
Basu, G. D., Innis, P., Deem, A. K., Starodynov, A., Udhane, S. S., Szelinger, S., Wang, M., Lobello, J. R., Baehner, F. L., Jean–Paul De La, O., et al. (2026) · Breast Cancer Research · doi:10.1186/s13058-025-02217-0 · Cited by 2
Self-citationNext Frontier in HER2+/HR+ Breast Cancer: Leveraging Cell Cycle Control with CDK4/6 Inhibitors
Poli, I., Oliva, G. R., Mongelli, G., Rotondi, A., Frescura, V., Arcuri, G., Garufi, G., Pontolillo, L., Mastrantoni, L., Monte, E. D., et al. (2026) · Journal of Personalized Medicine · doi:10.3390/jpm16030143 · Cited by 2
Therapeutic advances in HR+/HER2- advanced breast cancer after failure of CDK4/6 inhibitor therapy
Cui, M., Xiao, J., Ma, L., Liang, Y., & Liang, J. (2026) · Frontiers in Oncology · doi:10.3389/fonc.2026.1763278 · Cited by 3
“The core mechanism involves selective inhibition of cyclin-dependent kinases 4 and 6, which blocks retinoblastoma protein (RB) phosphorylation, thereby inhibiting the release of the transcription factor E2F.”
Shahraz, S., Wong, O. Y., Chotai, R., Knight, S., Globe, D., Patel, M. J., Kaushik, A., Aiyegbusi, O. L., & Calvert, M. (2026) · BMJ Oncology · doi:10.1136/bmjonc-2025-000942 · Cited by 3
Wang, J., Wang, Q., & Liu, J. (2023) · Science of Advanced Materials · doi:10.1166/sam.2023.4538 · Cited by 2
Cazzaniga, M. E., Pronzato, P., AMOROSO, D., Bernardo, A., Biganzoli, L., Bisagni, G., Blasi, L., Bria, E., Cognetti, F., Crinò, L., et al. (2023) · Cancers · doi:10.3390/cancers16010117 · Cited by 2
Follow-up of breast cancer: why is it necessary to start a Consensus in 2024?
Gori, S., Zambelli, A., Angiolini, C., Ferro, A., Rose, F. D., Fabi, A., Azzarello, G., Bogina, G. S., Cancian, M., Valerio, M., et al. (2024) · AboutOpen · doi:10.33393/ao.2024.2634 · Cited by 2
Azim, H. A., Saleh, M. A., Shibel, P. E. E., Abdelhafeez, A. A. M., Hassan, M. S., & Kassem, L. M. H. (2024) · Journal of Chemotherapy · doi:10.1080/1120009x.2024.2342741 · Cited by 2
Avxentyev, N. А., Andreyashkina, I. I., Артамонова, Е. В., Болотина, Л. В., Kovalenko, E. I., & Sisigina, N. (2024) · Tumors of female reproductive system · doi:10.17650/1994-4098-2024-20-1-64-81 · Cited by 2
Identifying drivers of first-line HR+/HER2− metastatic breast cancer treatment choices
Brufsky, A., Maculaitis, M. C., Kopenhafer, L., Olsen, P., Kurosky, S. K., Arruda, L. S., Heck, W. D., & Cha-Silva, A. S. (2024) · Future Oncology · doi:10.1080/14796694.2024.2350294 · Cited by 2
Lan, B., Peng, X., & Ma, F. (2024) · The Breast · doi:10.1016/j.breast.2024.103766 · Cited by 2
“…mainly due to the promotion of early cancer screening and diagnosis, as well as the application of many new antitumor drugs, such as cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) and antibody ‒ drug conjugates (ADCs), which have benefited from the rapid development of clinical research [4 – 9].”
BackgroundYıldırım, H. Ç., Büyükkör, M., Kavgacı, G., Çelik, B. Ş., Yucel, K. B., Dursun, B., Chalabiyev, E., Yılmaz, F., Yildirim, S. S., Kuş, F., et al. (2024) · Medicine · doi:10.1097/md.0000000000038828 · Cited by 2
Sacituzumab govitecan for hormone receptor–positive HER2-negative advanced breast cancer
Garrigós, L., Camacho, D., Pérez-García, J. M., Llombart‐Cussac, A., Cortés, J., & Antonarelli, G. (2024) · Expert Review of Anticancer Therapy · doi:10.1080/14737140.2024.2392775 · Cited by 2
“In the setting of HR+/HER2-ABC, since the landmark introduction of cyclin-dependent kinase 4/6 inhibitors (CDKi) plus endocrine therapy (ET) as the first-line regimen, given their improvements in median progression-free survival (mPFS), the median OS has reached approximately 5 years [7–9].”
Kubeczko, M., Gabryś, D., Rembak-Szynkiewicz, J., Gräupner, D., Polakiewicz-Gilowska, A., & Jarząb, M. (2024) · Radiotherapy and Oncology · doi:10.1016/j.radonc.2024.110639 · Cited by 2
Update on Pulmonary Toxicity Induced by New Breast Cancer Treatments
Belluzzi, L., Martinelli, G., Medici, B., Farina, A., Martinelli, E., Canino, F., Caggia, F., Molinaro, A., Barbolini, M., Tamburrano, F., et al. (2025) · Breast Cancer Targets and Therapy · doi:10.2147/bctt.s489419 · Cited by 3
Chen, Z.-L., Fu, Z., Zhang, N., Zou, W., & Chen, W. (2025) · BMC Pharmacology and Toxicology · doi:10.1186/s40360-025-00862-x · Cited by 3
Leigh, J., Lee, S. F., Fawaz, A., et al. (2025) · Current Opinion in Supportive and Palliative Care · doi:10.1097/spc.0000000000000749 · Cited by 2
“This improved to 38 months in 2010, and now in some breast cancer subsets such as hormone positive disease, the median OS has improved to 68 months [69,70].”
The SONIA trial shows the power and challenges of academic research
Paluch–Shimon, S., & Cardoso, F. (2025) · Nature Reviews Clinical Oncology · doi:10.1038/s41571-025-01004-2 · Cited by 2
Ceylan, F., Efil, S. C., Şener, D., Tenekeci, A. K., Bi̇lgi̇n, B., Yücel, Ş., Ceylan, E. G., Hızal, M., Şendur, M. A. N., Akıncı, M. B., et al. (2025) · Expert Review of Anticancer Therapy · doi:10.1080/14737140.2025.2490289 · Cited by 3
“…has highlighted several factors influencing survival outcomes, including the specific CDK4/6 inhibitor used (riboci-clib or palbociclib), the type of endocrine therapy administered (aromatase inhibitor or fulvestrant), the presence of visceral metastases, and radiological response status [6,19].”
Werutsky, G., Rosa, D. D., Reinert, T., Barroso‐Sousa, R., Resende, H. M., Signorini, P. A., Cronemberger, E. H., Fagundes, J. G. M., Leal, J. H. S., Guimarães, M. B., et al. (2025) · Clinical Breast Cancer · doi:10.1016/j.clbc.2025.05.020 · Cited by 4
Schneeweiß, A., Fasching, P. A., Thill, M., van Mackelenbergh, M., Marmé, F., Tesch, H., Fehm, T. N., Park‐Simon, T., Häberle, L., Uhrig, S., et al. (2025) · Journal of Cancer Research and Clinical Oncology · doi:10.1007/s00432-025-06246-2 · Cited by 2
Unveiling Epigenetic Regulatory Elements Associated with Breast Cancer Development
Jardanowska-Kotuniak, M., Dramiński, M., Wlasnowolski, M., Łapiński, M., Sengupta, K., Agarwal, A., Filip, A., Ghosh, N., Pancaldi, V., Grynberg, M., et al. (2025) · International Journal of Molecular Sciences · doi:10.3390/ijms26146558 · Cited by 3
“The largest number of them was targeted by palbociclib, ribociclib [65], and abemaciclib [66], among 19 others drugs (Table S7).”
Oikonomidou, O., Beresford, M. J., Galve-Calvo, E., Woeckel, A., Parikh, R. C., Hitchens, A., Chen, C., Doan, J. F., Li, B. C., Ansquer, V. D., et al. (2025) · Breast Cancer Research and Treatment · doi:10.1007/s10549-025-07707-5 · Cited by 2
Efficacy and Predictability of Cyclin-Dependent Kinase 4/6 Inhibitors in HER2-Positive Breast Cancer
Abbasi, M. S., Afzal, M. Z., Sarwar, T., & Gamlen, H. A. (2025) · Cancers · doi:10.3390/cancers17172788 · Cited by 2
“Ribociclib and abemaciclib followed a similar path, based on the results from the MONALEESA (2, 3, and 7) and MONARCH (1, 2, and 3) trials, respectively [45–51].”
Hao, C., Shi, J., Song, Y., Ma, J., Yang, H., Jia, Y., Song, C., Meng, W., & Zhang, J. (2025) · International Journal of Surgery · doi:10.1097/js9.0000000000003208 · Cited by 3
Ribociclib-Induced Hepatitis: A Case Report of Possible Autoimmune Hepatotoxicity
Leigh, J., Rivera, J., Alsulaiman, M., & Brezden‐Masley, C. (2025) · Case Reports in Oncology · doi:10.1159/000549179 · Cited by 3
“Outside of cyto-penias however, hepatotoxicity is one of the more common grade 3–4 toxicities with rates ranging from 7 to 12% [4, 5, 7].”
InfluentialSammons, S. L., Yardley, D. A., Sharma, P., Gadi, V. K., Pegram, M. D., Pathak, P., Hu, H., Sopher, G. M., & Fasching, P. A. (2025) · Oncology and Therapy · doi:10.1007/s40487-025-00394-8 · Cited by 2
“…improvement in over-all survival (OS) compared with ET alone in all 3 phase 3 RCTs (MONALEESA-2, hazard ratio [HR] 0.76 [95% CI 0.63–0.93; 2-sided P = 0.008]; MONALEESA-3, HR 0.72 [95% CI 0.57–0.92; 1-sided P = 0.00455]; and MONALEESA-7, HR 0.71 [95% CI 0.54–0.95; 1-sided P = 0.00973]) [6–8].”
InfluentialPharmacogenomic Impact on Breast Cancer Survival for Black Zimbabwean Patients on Tamoxifen
Mazhindu, T., Chase, E., Joel, M., et al. (2025) · JCO Global Oncology · doi:10.1200/go-25-00367 · Cited by 2
Targeting the JAK/STAT Signaling Pathway in Breast Cancer: Leaps and Hurdles
Aho, S., Coste, C., Purcari, L., Trédan, O., Poulard, C., Méry, B., Boisvert, F., & Romancer, M. L. (2025) · Biomedicines · doi:10.3390/biomedicines13123061 · Cited by 5
Optimizing hormone therapy for breast cancer: Translating gains to the early-stage setting
Chien, A. J., Kyalwazi, B., & Esserman, L. J. (2022) · Cell Reports Medicine · doi:10.1016/j.xcrm.2022.100664 · Cited by 2
“Predicting benefit in the early-stage setting and diverse enrollment in trials need to be priorities.(1)”
BackgroundBeddok, A., Porte, B., Cottu, P. H., Fourquet, A., & Kirova, Y. (2023) · Cancer/Radiothérapie · doi:10.1016/j.canrad.2022.11.003 · Cited by 2
Tong, Y., Xu, S., Jiang, L., et al. (2023) · Frontiers in Endocrinology · doi:10.3389/fendo.2023.1266679 · Cited by 2
Yang, P., Zhang, H., Wu, M., Zhao, F., Wang, M., Zhao, J., & Zhao, Y. (2024) · European Journal of Clinical Pharmacology · doi:10.1007/s00228-024-03757-8 · Cited by 3
CDK4/6 Inhibition in the Metastatic Setting: Where Are We Headed?
Sakach, E. A., Keskinkılıç, M., Wood, S. J., Canning, M. T., & Kalinsky, K. M. (2023) · Current Treatment Options in Oncology · doi:10.1007/s11864-023-01109-9 · Cited by 1
Julson, J. R., Hutchins, S. C., Quinn, C. H., Beierle, A. M., Bownes, L. V., Stewart, J. E., Aye, J. M., Yoon, K. J., & Beierle, E. A. (2023) · Journal of Pediatric Surgery · doi:10.1016/j.jpedsurg.2023.10.004 · Cited by 2
Manova, M. M., Arabadjiev, J. I., Mangaldzhiev, R., Dudov, A., Penchev, D., Hemetsberger, M., Sharkov, A., Zidarova, B., Apostolova, D., Vasileva, M., et al. (2023) · Biotechnology & Biotechnological Equipment · doi:10.1080/13102818.2023.2268753 · Cited by 2
Kubeczko, M., Gabryś, D., Polakiewicz-Gilowska, A., Bobek‐Billewicz, B., & Jarząb, M. (2024) · Pharmaceuticals · doi:10.3390/ph17070927 · Cited by 1
“In the context of ribociclib treatment assessed in MONALEESA studies, only radiotherapy with palliative regimens for bone pain was feasible [5,21,24].”
MethodRemilah, A. A., Krayim, B., Amir, E., Tibau, A., Robson, M. E., Abuhadra, N. K., Chen, Y., Shepshelovich, D., & Goldvaser, H. (2024) · Critical Reviews in Oncology/Hematology · doi:10.1016/j.critrevonc.2024.104455 · Cited by 1
Chae, H., Sim, S. H., Kwon, Y., Lee, E., Han, J., Jung, S., Lee, S., Kang, H., Kim, Y.-J., Kim, T. H., et al. (2024) · Cancers · doi:10.3390/cancers16183122 · Cited by 1
Schlam, I. M., Smith, D. M., Peer, C., Sissung, T. M., Schmidt, K. T., Tan, M. T., Chitalia, A., Bishopric, N. H., Steinberg, S. M., Choo‐Wosoba, H., et al. (2024) · npj Breast Cancer · doi:10.1038/s41523-024-00692-w · Cited by 1
Martos, T., Saint-Gerons, M., Masfarre, L., Castro-Henriques, M., Martinez‐García, M., Servitja, S., & Albanell, J. (2024) · Frontiers in Oncology · doi:10.3389/fonc.2024.1430341 · Cited by 2
Personalization of Endocrine Therapy in Hormone Receptor-Positive Breast Cancer
Fernandes, S., Batra, A., & Pushpam, D. (2024) · Springer eBooks · doi:10.1007/978-981-97-7755-6_24 · Cited by 1
Önder, T., Öner, İ., Karaçin, C., & Ateş, Ö. (2025) · International Journal of Clinical Oncology · doi:10.1007/s10147-025-02770-w · Cited by 1
Factors Affecting the Survival of Metastatic Breast Cancer Patients Treated with CDK 4/6 Inhibitors
İşleyen, Z. S., Muğlu, H., Topcu³, Z. A., Beşiroğlu, M., Yasin, A. İ., Topçu, A., Şimşek, M., Şeker, M., & Türk, H. M. (2025) · Medicina · doi:10.3390/medicina61071279 · Cited by 2
“In the MONALEESA-2 study, ribociclib demonstrated significant PFS and OS benefits when combined with an aromatase inhibitor (AI) to treat postmenopausal patients with HR-positive, HER2-negative advanced breast cancer [7].”
Thérapies ciblées en situation néoadjuvante dans le cancer du sein : place des iCDK4/6 et des iPARP
Papazyan, T., & Frenel, J. (2025) · Bulletin du Cancer · doi:10.1016/j.bulcan.2025.06.005 · Cited by 1
Ambere, G. D., Prajapati, D. N., Mathure, D. M., & Kumar, D. (2025) · Current Problems in Cancer · doi:10.1016/j.currproblcancer.2025.101235 · Cited by 1
Zhu, K., Omene, C. O., Stroup, A. M., Bandera, E. V., & Khosrow‐Khavar, F. (2025) · British Journal of Clinical Pharmacology · doi:10.1002/bcp.70183 · Cited by 1
Michel, L. L., Ziegler, P., Kreis, P., Hartkopf, A. D., Wallwiener, M., Häberle, L., John, N., Kolberg, H., Hadji, P., Tesch, H., et al. (2025) · European Journal of Cancer · doi:10.1016/j.ejca.2025.115689 · Cited by 1
Self-citationLei, T., Jiang, Y., Yang, K., et al. (2025) · Discover Oncology · doi:10.1007/s12672-025-03356-8 · Cited by 1
“As an mTOR inhibitor, rapamycin has been applied to aging-related diseases [70, 71]. ibociclib has been shown in many clinical trials to be effective in extending survival time in early-and late-stage BC [72, 73].”
Klocker, E. V., Dobrić, N., Graf, R., Beichler, C., Hlauschek, D., Suppan, C., Pancheri, L., Egle, D., Albertini, C., Bartsch, R., et al. (2025) · npj Breast Cancer · doi:10.1038/s41523-025-00805-z · Cited by 1
Huang, X. Y., Harada, S., Shi, W., Siegal, G. P., Anderson, S. A., Şahin, A. A., Khoury, K. E., & Yalnız, C. (2025) · Human Pathology · doi:10.1016/j.humpath.2025.105905 · Cited by 1
Inácio, H., Jorge, R., Costa, C. A., et al. (2025) · Cureus · doi:10.7759/cureus.89889 · Cited by 1
Serum Proteomics of Ribociclib‐Mediated Cardiovascular Toxicity: An Exploratory Case–Control Study
Fiste, O., Samiotaki, M. K., Manios, E. D., Trika, C. O., Liacos, C., Dimitrakakis, C., Dimopoulos, M. A., Gavriatopoulou, M., & Zagouri, F. (2025) · PROTEOMICS - CLINICAL APPLICATIONS · doi:10.1002/prca.70021 · Cited by 1
Oruç, A. F., Erol, M., Şahin, Ö., Eryılmaz, M. K., Araz, M., & Artaç, M. (2025) · Current Oncology · doi:10.3390/curroncol32090510 · Cited by 1
“Ribociclib is the only drug in this class that has demonstrated benefits in both progression-free survival (PFS) and overall survival (OS) [4].”
Gadgil, S. N., Karve, A. S., Gudelsky, G. A., et al. (2025) · Molecular Cancer Therapeutics · doi:10.1158/1535-7163.mct-25-0277 · Cited by 1
Chávez‐MacGregor, M., Gligorov, J., Mouta, J., Meerveld, M. V., Wolkensdorfer, Z., Attfield, G., Lewis, A., & Cardoso, F. (2025) · The Breast · doi:10.1016/j.breast.2025.104607 · Cited by 1
“The greatest improvement has been achieved for people with HR-positive HER2-negative ABC, with many new treatment approvals, including the major breakthrough of CDK4/6 inhibitors, substantially prolonging OS in the clinical-trial setting [17 – 19, 21, 23, 24, 37].”
Long-term outcomes with adjuvant CDK4/6 inhibitors: who benefits most?
O’Meara, T. A., & Burstein, H. J. (2025) · Annals of Oncology · doi:10.1016/j.annonc.2025.10.012 · Cited by 1
Kong, A. M., Andrean, D., Khan, S., et al. (2025) · Journal of Comparative Effectiveness Research · doi:10.57264/cer-2025-0026 · Cited by 1
“The Kaplan Meier curve included in the MONALEESA-2 publication shows that the OS benefit of ribociclib began to emerge at approximately 20 months and continued to increase with longer follow-up, as indicated by survival at 5 years and 6 years [16] .”
InfluentialLong‐Term Management of Breast Cancer Bone Metastases: Two Case Reports
Lin, X., & Zeng, R. (2025) · International Journal of Breast Cancer · doi:10.1155/ijbc/9601887 · Cited by 1
“In patients with bone-only metastases, OS was reported to be 63.5 months in the PALOMA-2 trial [3] and 72.6 months in the MONALEESA-2 trial [4].”
InfluentialSEOM-GEICAM-SOLTI clinical guidelines in advanced breast cancer (UPDATE 2025)
García-Sáenz, J. Á., Blancas, I., Echavarría, I., Hinojo, C., Vila, M. M., Antón, F. M., Pernas, S., y Cajal, T. R., Ribelles, N., & Bellet, M. (2025) · Clinical & Translational Oncology · doi:10.1007/s12094-025-04102-w · Cited by 2
“Ribociclib was demonstrated to significantly improve overall survival (OS) in the first-line setting in the MONALEESA-2, 3, and 7 trials [26–28]: MONALEESA-7 was conducted exclusively in premenopausal women [27], while MONALEESA-3 also included hormone-resistant patients [28].”
Alloubani, A., Nimer, R. M., Farhan, F., Eid, F., & Khawaja, Y. (2025) · Seminars in Oncology Nursing · doi:10.1016/j.soncn.2025.152054 · Cited by 2
Zhang, G., Ni, H., Mishieva, L., Bartels, S., Christgen, M., Christgen, H., Kandt, L. D., Raap, M., Kates, R. E., Gluz, O., et al. (2025) · ESMO Open · doi:10.1016/j.esmoop.2025.105913 · Cited by 2
“47 The success of CDK4/6 inhibitors, which are suggested to act both on tumor cells and on the tumor immune environment, highlights the complex interplay between intrinsic tumor properties (differentiation state) and extrinsic factors (microenvironment) in dictating therapeutic response.”
Vitiligo associated with ribociclib therapy: a rare case report
Wang, Z., Bai, Y., Wu, R., Liu, Y., Dong, C., & Chen, L. (2025) · Frontiers in Oncology · doi:10.3389/fonc.2025.1669407 · Cited by 1
Patritumab deruxtecan in breast cancer treatment: a drug evaluation
Sabău, A., Paparo, J., Cheikh-Hussin, R., et al. (2025) · Future Oncology · doi:10.1080/14796694.2025.2598217 · Cited by 1
Dhungana, R., Prasai, P., Paudel, B., Ranabhat, K., Sapkota, S., & Shrestha, S. (2025) · Clinical Medicine Insights Oncology · doi:10.1177/11795549251402955 · Cited by 1
“17,19,20,23 The hazard ratio (HR) for OS was 0.76 (95% CI [0.68, 0.85]) favoring Ribociclib plus ET compared with ET alone ( P .001).”
InfluentialPogoda, K., Pawlik, H., Balata, A., Czopowicz, M., Bak, A., Twardowska, I., Meluch, M., Wojda, M., Mlodzinska, A., Szombara, E., et al. (2025) · Breast Cancer Targets and Therapy · doi:10.2147/bctt.s567687 · Cited by 2
Welslau, M., Fasching, P. A., Semmler-Lins, N., Mueller, L., Belleville, E., Rieger, L., Uhrig, S., Zahn, M., Lex, B., Uleer, C., et al. (2025) · The Breast · doi:10.1016/j.breast.2025.104684 · Cited by 1
Graziosi, A., Pane, R., Tinazzo, E., Basso, M., Avantaggiato, M., Schianchi, A., Canella, M., Melis, M., Nani, A., Re, M. D., et al. (2025) · Systematic Reviews · doi:10.1186/s13643-025-03046-0 · Cited by 1
Cazzaniga, M. E., Cogliati, V., Rossi, E., Paris, I., Borella, F., Moretti, G., Garrone, O., Pistelli, M., Palumbo, R., Ferro, A., et al. (2026) · ESMO Real World Data and Digital Oncology · doi:10.1016/j.esmorw.2025.100665 · Cited by 1
“4.”
Chmielewska-Krzesińska, M. (2026) · Animals · doi:10.3390/ani16020232 · Cited by 2
“Notably, toxicities are reversible and manageable by reducing the dose to 5.71 mg/kg/day (400 mg/day) or 2.85 mg/kg/day (200 mg/day) [43,109].”
InfluentialConte, B., Brasó‐Maristany, F., Pascual, T., Hernándo, C., Vázquez, S., Blanch, S., Oliveira, M., Virizuela, J. A., Muñoz-Mateu, M., Seguí, E., et al. (2026) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-25-2570 · Cited by 1
Pan, Y., Duan, C., Du, J., Zhang, J., Du, K., Zhang, C., Liu, Z., Zhang, W., Wang, B., Ren, Y., et al. (2026) · Annals of Surgical Oncology · doi:10.1245/s10434-026-19176-1 · Cited by 2
Han, L., Jin, Y.-F., Li, L., & Jiang, S. (2026) · Journal of Biomolecular Structure and Dynamics · doi:10.1080/07391102.2026.2631673 · Cited by 1
“Moreover, Ribociclib demonstrates a significant overall survival benefit in patients with HR þ /HER2-advanced breast cancer (Hortobagyi et al., 2022).”
Brufsky, A., Finn, R. S., Metzger, O., et al. (2026) · Breast Cancer Research and Treatment · doi:10.1007/s10549-026-07935-3 · Cited by 1
Villarreal-Garza, C. M., Meraz-Brenez, A., Reyes-Morales, A., Mushtaq, A. W., Moreno‐Jaime, B., Landaverde, D., Petracci, F. E., Idrobo, H., Moreno-Ríos, J., Pérez-Vargas, J. C. S., et al. (2026) · JCO Global Oncology · doi:10.1200/go-25-00425 · Cited by 1
Davis, N. E., Herrmann, J., Hodge, D. O., et al. (2026) · International Journal of Cardiology · doi:10.1016/j.ijcard.2026.134466 · Cited by 1
Ligorio, F., Provenzano, L., Fotia, G., Dieci, M. V., Curigliano, G., Giuliano, M., Botticelli, A., Lambertini, M., Rizzo, G., Pedersini, R., et al. (2026) · The Breast · doi:10.1016/j.breast.2026.104769 · Cited by 1
Yao, S., Imoto, S., Tsuchiya, A., Isaka, H., Seki, H., Asaga, S., Yokoi, S., Koneri, K., Maeda, H., & Goi, T. (2026) · Medicina · doi:10.3390/medicina62040661 · Cited by 1
“Recently, clinical trials have examined treatment sequences in patients with HR-positive, HER2-negative advanced or recurrent breast cancer, comparing the use of first-line CDK4/6i to that of deferred therapy (Table 1) [11–16].”
Reframing RB Tumor Suppressor Dysfunction as a Therapeutic Vulnerability in Cancer
Malko, R., Shannon, H. E., Dobrota, E. A., Kreklau, K. E., Stevens, L. K., Jackson, K. W., Saadatzadeh, M. R., Pandya, P. H., & Pollok, K. E. (2026) · Cancers · doi:10.3390/cancers18071175 · Cited by 1
Browne, I. M., Wong, H. C., Irfan, T., Chan, C., Johnston, S. R. D., Kemp, Z., Kipps, E., Parton, M., Turner, N. C., & Okines, A. F. C. (2026) · Cancers · doi:10.3390/cancers18081191 · Cited by 1
Scafetta, R., Donato, M., Gullotta, C., Guarino, A., Fiore, C., Sisca, L., Speziale, E., Troiano, R., Foderaro, S., Venuti, F., et al. (2026) · The Oncologist · doi:10.1093/oncolo/oyag146 · Cited by 1
Individualizing treatment sequence in metastatic luminal breast cancer
Suppan, C. (2026) · memo - Magazine of European Medical Oncology · doi:10.1007/s12254-026-01110-6 · Cited by 1
PIK3CA mutation testing and alpelisib use in metastatic breast cancer: a real-world data set
Danese, M. B. D., Vannas, C., Fagman, H., Karlsson, P. O., & Larsson, K. F. (2026) · Acta Oncologica · doi:10.2340/1651-226x.2026.45589 · Cited by 1
“First line treatment with endocrine therapy (ET) with or without cyclin dependent kinase 4/6-inhibitors (CDK4/6i) has significantly improved median OS, which currently is approximately 5 years [3–5].”
Cebeci, S., Birsin, Z., Jeral, S., Abbasov, H., Aliyev, V., Çerme, E., Çiçek, E., Atak, S., Günaltılı, M., Guliyev, M., et al. (2026) · Journal of Clinical Medicine · doi:10.3390/jcm15103736 · Cited by 2
“Several factors may influence the response rate to CDK 4/6 inhibitors, including the presence of visceral metastases, endocrine sensitivity, and menopausal status [1].”
A hypermetabolic pulmonary lesion in a patient with breast cancer
Franco, G., Promi, S., Galbardi, I., et al. (2026) · Breathe · doi:10.1183/20734735.0042-2026 · Cited by 1
“…mild clinical presentation of lung toxicity, the rapid improvement observed after treatment interruption and corticosteroid therapy, and the significant oncological benefit in improving progression-free survival and overall survival in patients with hormone receptor-positive breast cancer [1, 2].”
Targeting PFKFB3 to enhance CDK4/6 inhibitor response in ER+ breast cancer
Telang, S., Clem, B. F., Miret, A. A. H., Price, L., Dougherty, S. M., Schmitz, A., Yin, X., Ma, X., Zhang, X., Chesney, J., et al. (2026) · Breast Cancer Research · doi:10.1186/s13058-026-02336-2 · Cited by 1
“Compared with endocrine therapy alone, CDK4/6 inhibitor combinations nearly double progression-free survival and significantly improve overall survival [8–10].”
Kirchmair, A., Galassi, C., Torralba, E. G., Trajanoski, Z., Buqué, A., & Galluzzi, L. (2026) · Genes and Immunity · doi:10.1038/s41435-026-00409-y · Cited by 1
Sharaf, B., Omari, Z., Alzoubi, Q., et al. (2026) · Cancers · doi:10.3390/cancers18172894 · Cited by 1
“Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) combined with endocrine therapy are standard treatment for hormone receptor-positive (HR+), HER2-negative metastatic breast cancer (MBC) [2,3].”
Pyrazolo[4,3-H]quinazolines as Cyclin-dependent Kinase Inhibitors for Treating Cancer
De, S. K. (2023) · Current Medicinal Chemistry · doi:10.2174/0929867330666230525160458 · Cited by 1
Metadata
- Authors
- Hortobagyi, G. N., Stemmer, S. M., Burris, H. A., Yap, Y.-S., Sonke, G. S., Hart, L., Campone, M., Petrakova, K., Winer, E. P., Janni, W., Conte, P., Cameron, D. A., André, F., Arteaga, C. L., Zarate, J. P., Chakravartty, A., Taran, T., Le Gac, F., Serra, P., & O’Shaughnessy, J.
- Affiliations
- From the Department of Breast Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (G.N.H.), and Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center (C.L.A.), and Baylor University Medical Center, Texas Oncology, US Oncology (J.O.), Dallas — all in Texas; the Institute of Oncology, Davidoff Center, Rabin Medical Center, Tel Aviv University, Tel Aviv, Israel (S.M.S.); Sarah Cannon Research Institute, Nashville (H.A.B.); the Department of Medical Oncology, National Cancer Centre Singapore, Singapore (Y.-S.Y.); the Department of Medical Oncology, Netherlands Cancer Institute and Borstkanker Onderzoek Groep Study Center, Amsterdam (G.S.S.); Florida Cancer Specialists, Sarah Cannon Research Institute, Fort Myers (L.H.); the Department of Medical Oncology, Institut de Cancérologie de l’Ouest–René Gauducheau, Saint-Herblain (M.C.), and the Department of Medical Oncology, Institut Gustave Roussy, Medical School, Université Paris-Saclay, Villejuif (F.A.) — both...
- The University of Texas MD Anderson Cancer Center (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2022-03-10
- Volume
- 386
- Issue
- 10
- Pages
- 942-950
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W4220709633
- Cited by
- 791
- References
- 30
- Citations by year
- 2026: 177 · 2025: 226 · 2024: 200 · 2023: 150 · 2022: 38
- FWCI
- 99.29
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Edinburgh Research Explorer (University of Edinburgh) (publishedVersion, other-oa)
- Funders
- Novartis Pharmaceuticals Corporation (N/A)
- Topics
- Health Sciences › Medicine › Oncology › Advanced Breast Cancer Therapies
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
- Health Sciences › Medicine › Oncology › PARP inhibition in cancer therapy
- Keywords
- ribociclib, letrozole, advanced breast cancer, hormone receptor-positive HER2-negative breast cancer, overall survival, first-line therapy, CDK4/6 inhibitors, postmenopausal women, progression-free survival
- MeSH terms
- Letrozole, Aged, Aminopyridines, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Female, Humans, Middle Aged, Neutropenia, Purines, Receptors, Estrogen, Survival Analysis, Erb-b2 Receptor Tyrosine Kinases, Intention to Treat Analysis, Neoplasm Grading
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
A language model drew the claims from the paper on 2026-09-30, under version 3 of the claim definition (model deepseek-v4.1-flash, prompt extract-v3).
A second model labelled each claim on 2026-09-30 (model jev-1.13-20260917, definition revision gold-guideline-v0.2).
Cited sources are checked with a language model’s help (gpt-6-sol).
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review