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Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer
Open accessAbstract
BACKGROUND: The inhibition of cyclin-dependent kinases 4 and 6 (CDK4/6) could potentially overcome or delay resistance to endocrine therapy in advanced breast cancer that is positive for hormone receptor (HR) and negative for human epidermal growth factor receptor 2 (HER2). METHODS: . RESULTS: for superiority). The median duration of follow-up was 15.3 months. After 18 months, the progression-free survival rate was 63.0% (95% confidence interval [CI], 54.6 to 70.3) in the ribociclib group and 42.2% (95% CI, 34.8 to 49.5) in the placebo group. In patients with measurable disease at baseline, the overall response rate was 52.7% and 37.1%, respectively (P<0.001). Common grade 3 or 4 adverse events that were reported in more than 10% of the patients in either group were neutropenia (59.3% in the ribociclib group vs. 0.9% in the placebo group) and leukopenia (21.0% vs. 0.6%); the rates of discontinuation because of adverse events were 7.5% and 2.1%, respectively. CONCLUSIONS: Among patients receiving initial systemic treatment for HR-positive, HER2-negative advanced breast cancer, the duration of progression-free survival was significantly longer among those receiving ribociclib plus letrozole than among those receiving placebo plus letrozole, with a higher rate of myelosuppression in the ribociclib group. (Funded by Novartis Pharmaceuticals; ClinicalTrials.gov number, NCT01958021 .).
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In the citing paper
“The last 2 years have seen the establishment of cyclin-dependent kinase (CDK)4/6 inhibitors combined with endocrine therapy (ET) as the standard of care for ER-positive/HER2-negative ABC”
From 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) (2020) · cites this paper as [44]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“substantial PFS benefit and good toxicity profile.36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57”
From 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) (2020) · cites this paper as [44]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“These agents can be combined with an aromatase inhibitor (AI) or fulvestrant, and are effective in de novo or recurrent ABC, in first or second line, in cases of primary or secondary resistance, in postmenopausal and premenopausal women (the latter with ovarian function suppression/ablation), and in men (preferably with a luteinising hormone-releasing hormone agonist).”
From 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) (2020) · cites this paper as [44]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing 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”
From Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. (2022) · cites this paper as [10]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing 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).”
From Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. (2022) · cites this paper as [10]
Experimental — accuracy not yet measured
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
“Data for overall survival were immature at the time of the primary and updated analyses.”
From Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. (2022) · cites this paper as [10]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing 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).”
From Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. (2022) · cites this paper as [10]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing 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”
From Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. (2022) · cites this paper as [10]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing 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.”
From Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. (2022) · cites this paper as [10]
In the citing paper
“However, 10% of the patients treated with abemaciclib develop grade 3 diarrhea, which is very rare with the other two inhibitors (Asghar et al., 2015; Hortobagyi et al., 2016).”
From CDK4/6 Inhibitors: The Mechanism of Action May Not Be as Simple as Once Thought (2018) · cites this paper as Hortobagyi et al., 2016
In the citing paper
“Abemaciclib appears to be better tolerated overall, with only 55% of patients experiencing significant adverse events (as compared to 70–80% with ribociclib and palbociclib) and only 21% with grade 3–4 neutropenia.”
From CDK4/6 Inhibitors: The Mechanism of Action May Not Be as Simple as Once Thought (2018) · cites this paper as Hortobagyi et al., 2016
In the citing paper
“Grade 3–4 neutropenia is observed in approximately 60% of patients taking palbociclib and ribociclib (Asghar et al., 2015; Hortobagyi et al., 2016).”
From CDK4/6 Inhibitors: The Mechanism of Action May Not Be as Simple as Once Thought (2018) · cites this paper as Hortobagyi et al., 2016
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Citations
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An Update on the Clinical Use of CDK4/6 Inhibitors in Breast Cancer
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ResultInfluentialUpdate Breast Cancer 2020 Part 4 – Advanced Breast Cancer
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BackgroundSelf-citationGuarneri, V., Giorgi, C. A., Cinieri, S., Bengala, C., Mariani, G., Bisagni, G., Frassoldati, A., Zamagni, C., Rossi, C. D., Amoroso, V., et al. (2021) · European Journal of Cancer · doi:10.1016/j.ejca.2021.05.008 · Cited by 13
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“In line with such a combinatorial approach, the addition of palbociclib (or ribociclib) to an aromatase inhibitor (or ER antagonist) achieves significant PFS benefit for patients with ER?HER2- breast cancer and was recently (or is about to be) approved by the US Food and Drug Administration for the treatment of this e…”
BackgroundChalasani, P. (2017) · Oncology · doi:10.1159/000477404 · Cited by 13
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Cdk4/6 inhibitors and overall survival: power of first-line trials in metastatic breast cancer
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“72].(7) Superimposable number of included patients and results have been reported with ribociclib in a second pivotal trial, MONALEESA-7, that was conducted in premenopausal women [8].”
Büyükkaramikli, N., de Groot, S., Riemsma, R., Fayter, D., Armstrong, N., Portegijs, P. J. M., Duffy, S., Kleijnen, J., & Al, M. (2018) · PharmacoEconomics · doi:10.1007/s40273-018-0708-4 · Cited by 16
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A clinical evaluation of treatments that target cell cycle machinery in breast cancer
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“Different phase III studies (Paloma2 [38], Monaleesa2 [39], Monaleesa7 [40], Monarch3 [41] explored the first line treatment with palbociclib, ribociclib, abemaciclib plus an aromatase inhibitor or tamoxifen versus endocrine therapy alone in post and premenopausal patients.”
BackgroundPaul, D., Vukelja, S. J., Holmes, F. A., Blum, J. L., McIntyre, K. J., Lindquist, D. L., Osborne, C. R. C., Sanchez, I. J., Goldschmidt, J. H., Wang, Y., et al. (2019) · npj Breast Cancer · doi:10.1038/s41523-019-0132-8 · Cited by 13
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“With the discovery of cyclin-dependent kinase (CDK) 4/6 inhibitors, the progression-free survival (PFS) is almost doubled when combination of CDK4/6 inhibitors and aromatase inhibitors (AIs) as the first line treatment of HR+/HER2- mBC/ABC patients (Table 1) (7-9).”
BackgroundUnexpected toxicity of CDK4 /6 inhibitor palbociclib and radiotherapy
van Aken, E. S. M., Beeker, A., Houtenbos, I., Pos, F. J., Linn, S. C., Elkhuizen, P. H. M., & de Jong, M. C. (2021) · Cancer Reports · doi:10.1002/cnr2.1470 · Cited by 13
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“This result was also achieved in the group of patients carrying PIK3CA or TP53 mutations.38 Conversely, in the three randomized trials that led to the approval of ribociclib, 26 patients who had a RB1 mutation detected in the baseline ctDNA did not benefit from the administration of ribociclib in addition to ET.7,8,39…”
BackgroundSpring, L. M., Scarpetti, L., Medford, A. J., Niemierko, A., Comander, A. H., Mulvey, T. M., Schnipper, L. E., Isakoff, S. J., Moy, B., Wander, S. A., et al. (2025) · npj Breast Cancer · doi:10.1038/s41523-024-00708-5 · Cited by 13
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“Briefly, PALOMA-1 and PALOMA-2 [8,9] have studied palbociclib + AI vs. placebo, MONALEESA-2 [20] ribociclib vs. placebo and MONARCH-3 [21] abemaciclib vs. placebo in patients not previously treated for MBC. PALOMA-3 for palbociclib [14], MONALEESA3 for ribociclib [16] and MONARCH-2 for abemaciclib [18] have showed the…”
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“The analysis of the effects of RI in patients with cancer was performed using pooled data from the following studies: a first-in-human phase I study of ribociclib as a single agent in patients with advanced solid tumors or lymphomas (X2101 [NCT01237236]) [9], a phase I study of ribociclib in Asian patients with advanc…”
MethodSelf-citationRugo, H. S., Harmer, V., O’Shaughnessy, J., Jhaveri, K. L., Tolaney, S. M., Cardoso, F., Bardia, A., Maheshwari, V. K., Tripathi, S., Haftchenary, S., et al. (2023) · Therapeutic Advances in Medical Oncology · doi:10.1177/17588359231152843 · Cited by 12
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“Of note, a few selective CDK4/CDK6 inhibitors like ribociclib [2] and palbociclib [3] have been proven to be highly effective for improving the overall survival (OS) of estrogen receptor (ER)-expressing breast cancer patients.”
BackgroundZhao, M., Hanson, K. A., Zhang, Y., Zhou, A., & Cha-Silva, A. S. (2023) · Targeted Oncology · doi:10.1007/s11523-023-00957-7 · Cited by 13
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Implications of TGFβ Signaling and CDK Inhibition for the Treatment of Breast Cancer
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“MONALEESA-2 examined the efficacy of the ribociclibletrozole combination therapy in 668 postmenopausal women with HR+, HER2− recurrent or metastatic breast cancer that had not previously received treatment for advanced disease.”
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Parati, M. C., Pedersini, R., Perego, G., Reduzzi, R., Savio, T., Cabiddu, M., Borgonovo, K., Ghilardi, M., Luciani, A., & Petrelli, F. (2022) · Breast Cancer Targets and Therapy · doi:10.2147/bctt.s341857 · Cited by 14
“The primary endpoint was PFS, and the secondary endpoints were OS, overall response rate (ORR), clinical benefit rate, safety, and quality of life assessments.(3) In the MONALEESA-7 trial, researchers evaluated pre/perimenopausal patients with HR+, HER2 negative advanced BC who received treatment with either RIBO, a p…”
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“CDK6 mRNA expression, CCND1 amplification, and p16 loss) have thus far been unable to demonstrate a biomarkertreatment interaction to predict PFS with CDK4/6 inhibitors, despite a mechanistic rationale (Table 3).(6,8,16,18-20,24-35,38,39)”
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Predictive biomarkers for molecularly targeted therapies and immunotherapies in breast cancer
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Optimizing CDK4/6 inhibitors in advanced HR+/HER2- breast cancer: A personalized approach
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“Age I: 62 (23-91) C: 63 (29-88) I: 63 (31-89) C: (63 (34-86) I: 43 (25-58) C: 45 (29-58) I: 59 (32-91) C: 62 (32-87) I: 63 (38-87) C: 63 (32-88) I: 54 (32-83) C: 54 (27-77) I: 63 (54-71) C: 64 (56-70) I: 62 (30-89) C: 61 (28-88) I: 57 (30-88) C: 56 (29-80)”
Ren, X., Yan, C., Tian, L., & Cui, X. (2022) · International Journal of Immunopathology and Pharmacology · doi:10.1177/03946320221145520 · Cited by 12
“5% of patients in the MONALEESA-2 trial).(3,7,9) Only one patient experienced nonserious febrile neutropenia in the abemaciclib arm in the Monarch 3 trial.”
BackgroundResultInfluentialBastiaannet, E., Charman, J., Johannesen, T. B., Schrodi, S., Siesling, S., Eycken, L. J. V., Walsh, P. M., Audisio, R. A., Boelens, P. G., Rubio, I. T., et al. (2017) · Clinical Breast Cancer · doi:10.1016/j.clbc.2017.11.019 · Cited by 12
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Results From a Health Insurer's Clinical Pathway Program in Breast Cancer
Gautam, S., Sylwestrzak, G., Barron, J. O., Chen, X., Eleff, M. K., Debono, D. J., Nguyen, A., & Fisch, M. J. (2018) · Journal of Oncology Practice · doi:10.1200/jop.18.00157 · Cited by 12
Pharmacokinetic drug evaluation of abemaciclib for advanced breast cancer
Robert, M., Frenel, J., Bourbouloux, E., Rigaud, D. B., Patsouris, A., Augereau, P., Gourmelon, C., & Campone, M. (2018) · Expert Opinion on Drug Metabolism & Toxicology · doi:10.1080/17425255.2019.1559816 · Cited by 12
“CDK4/6 inhibitors now represent a cornerstone for the treatment of ER-positive MBC.”
MethodInfluentialSelf-citationRibociclib-associated vortex keratopathy
Saeed, D., & Hussain, A. (2020) · Canadian Journal of Ophthalmology · doi:10.1016/j.jcjo.2019.11.003 · Cited by 12
Xie, N., Qin, T., Ren, W., Yao, H., Yu, Y., & Hong, H. (2020) · Cancer Management and Research · doi:10.2147/cmar.s254365 · Cited by 12
Therapy Algorithms for the Diagnosis and Treatment of Patients with Early and Advanced Breast Cancer
Schneeweiß, A., Bauerfeind, I., Fehm, T. N., Janni, W., Thomssen, C., Witzel, I., Wöckel, A., Müller, V., & on behalf of the Commission Breast of the Working Group Gynecologic Oncology (AGO) (2020) · Breast Care · doi:10.1159/000511925 · Cited by 12
Self-citationPancreatic adenocarcinoma: molecular drivers and the role of targeted therapy
Al-Share, B. A., Hammad, N., & Diab, M. (2021) · Cancer and Metastasis Reviews · doi:10.1007/s10555-020-09948-w · Cited by 12
Cardoso, F., Cella, D. F., Velikova, G., Harmer, V., Schumacher-Wulf, E., Rihani, J., Casas, A., & Harbeck, N. (2021) · Cancer Treatment Reviews · doi:10.1016/j.ctrv.2021.102321 · Cited by 13
ENDORSE: a prognostic model for endocrine therapy in estrogen‐receptor‐positive breast cancers
Nath, A., Cohen, A. L., & Bild, A. (2022) · Molecular Systems Biology · doi:10.15252/msb.202110558 · Cited by 12
Decoding breast cancer: insights into molecular pathways & therapeutic approaches
Laskar, T. T., Laskar, H. M., Mazumder, J. A., Bhattacharjee, R., Husain, M. I., Das, B., Das, P., Choudhury, P. D., Arora, M., Borah, S., et al. (2025) · Discover Oncology · doi:10.1007/s12672-025-03764-w · Cited by 16
Breast Cancer: Molecular Pathogenesis, Targeted Therapy, Screening, and Prevention
Lei, H., Fu, J., Gu, W., Qiao, H., Guo, H., Chen, Z., Wang, S. M., & Chen, T. (2026) · MedComm · doi:10.1002/mco2.70560 · Cited by 15
“This contrasts with the MONALEESA-2 trial, where ribociclib plus letrozole conferred a clear OS advantage of more than 12 months [ 134 ].”
Homologous recombination deficiency and hemizygosity drive resistance in breast cancer
Safonov, A. M., Lee, M. K., Brown, D. N., Bielo, L. B., Mehine, M. M., Bandlamudi, C., O’Leary, B., Shao, H., Vicente, L., Muldoon, D. M., et al. (2026) · Nature · doi:10.1038/s41586-026-10197-0 · Cited by 13
“CDK4/6i combined with endocrine therapy (CDK4/6i + ET) represents the cornerstone of treatment for patients with metastatic and high-risk early-stage HR + /breast cancer 36–38 , with RB1 loss established as a key mechanism of resistance to CDK4/6i 39 .”
Vitiligo-like lesions associated with ribociclib in a woman with metastatic breast cancer
Türkel, A., Karaçin, C., Öner, İ., Şeyran, E., & Öksüzoğlu, B. Ç. (2023) · Journal of Oncology Pharmacy Practice · doi:10.1177/10781552231156521 · Cited by 11
Ribociclib-induced hepatotoxicity
Er, M. M., Araz, M., Hendem, E., Eryılmaz, M. K., & Artaç, M. (2023) · Journal of Oncology Pharmacy Practice · doi:10.1177/10781552231154009 · Cited by 11
“Therefore, monitoring of transaminases in patients receiving ribociclib is recommended.(6) Here, we report the case of a rechallenge of a CDK 4/6 inhibitor after grade 3 liver toxicity.”
BackgroundSuo, J., Zhu, K., Zhuang, C., Zhong, X., Bravaccini, S., Maltoni, R., Bertucci, F., Zheng, H. Y., & Luo, T. L. (2023) · Annals of Translational Medicine · doi:10.21037/atm-23-1913 · Cited by 10
Dajsakdipon, T., Susiriwatananont, T., Wongkraisri, C., Ithimakin, S., Parinyanitikul, N., Supavavej, A., Dechaphunkul, A., Sunpaweravong, P., Neesanun, S., Akewanlop, C., et al. (2024) · BMC Cancer · doi:10.1186/s12885-024-12765-x · Cited by 13
“Our real-world finding aligned with MONALEESA and PALOMA-2 trials [7, 12, 17] and previous RWE trials [30–34].”
ResultTripathy, D., Blum, J. L., Karuturi, M. S., McCune, S. L., Kurian, S., Moezi, M. M., Anderson, D., Gauthier, E. R., Zhang, Z., Montelongo, M. Z., et al. (2024) · The Oncologist · doi:10.1093/oncolo/oyae291 · Cited by 12
Chen, Y., Xie, Y., Sang, D., Xie, N., Han, X., Zhao, Y., Li, J., Yue, J., Yuan, P., & Wang, B. (2024) · Therapeutic Advances in Medical Oncology · doi:10.1177/17588359241302018 · Cited by 11
Aslan, M., Aslan, Y., & Levent, A. (2025) · Diamond and Related Materials · doi:10.1016/j.diamond.2025.112001 · Cited by 11
Zeng, C., Gao, Y., Lan, B., Wang, J., & Ma, F. (2025) · Seminars in Cancer Biology · doi:10.1016/j.semcancer.2025.05.009 · Cited by 12
Elkotamy, M. S., Elkelesh, I. A., Giovannuzzi, S., Ismail, R. S. M., El-Refaie, W. M., Almehizia, A. A., Naglah, A. M., Nocentini, A., Supuran, C. T., Farès, M., et al. (2025) · European Journal of Medicinal Chemistry · doi:10.1016/j.ejmech.2025.117752 · Cited by 11
Lloyd, M. R., Chica-Parrado, M. D. R., Weipert, C. M., Knepper, T. C., Podany, E. L., Napolitano, F., Ye, D., Lin, C.-C. A., Uemoto, Y., Liao, J., et al. (2025) · EBioMedicine · doi:10.1016/j.ebiom.2025.105828 · Cited by 11
“…result that median PFS in the multicentre cohort was well below typical responses expected in routine practice based on prospective trials, 42,43,69 supported our conduct of validation studies using real-world evidence and preclinical models to compare CDK4/6i sensitivity in tumours with and…”
Self-citationNot So Fast: Cultivating miRs as Kinks in the Chain of the Cell Cycle
Schiewer, M. J., & Knudsen, K. E. (2017) · Cancer Cell · doi:10.1016/j.ccell.2017.03.012 · Cited by 11
“More recently, the CDK4/6i ribociclib was FDA approved for this same patient population in combination with letrozole, based on clinical data indicating that the combination lengthened PFS (Hortobagyi et al., 2016).”
BackgroundKomorowski, A. S., MacKay, H. J., & Pezo, R. C. (2020) · Cancer Medicine · doi:10.1002/cam4.3095 · Cited by 11
Migliaccio, I., Leo, A., Galardi, F., Guarducci, C., Fusco, G. M., Benelli, M., Leo, A. D., Biganzoli, L., & Malorni, L. (2021) · Cancers · doi:10.3390/cancers13112640 · Cited by 12
“MONALEESA-2 [6] 3 MBC I line Ribo and Let vs.”
BackgroundInfluentialCanino, F., Piacentini, F., Omarini, C., Toss, A., Barbolini, M., Vici, P., Dominici, M., & Moscetti, L. I. (2022) · International Journal of Molecular Sciences · doi:10.3390/ijms23137079 · Cited by 12
“These samples belonged to a total of 5263 pts with mBC treated in seven different randomized controlled phase III clinical trials: EGF30008, BOLERO-2, PALOMA-2,3, and MONALEESA-2,3,7.”
BackgroundAltena, R., Bajalica‐Lagercrantz, S., & Papakonstantinou, A. (2022) · Cancers · doi:10.3390/cancers14194665 · Cited by 11
“Moreover, CDK4/6 inhibitors have not demonstrated significant increase in other types of cardiovascular toxicity such as coronary artery disease, thrombo-embolic events, or cardiomyopathy [44,45].”
BackgroundMastrantoni, L., Orlandi, A., Palazzo, A., Garufi, G., Fabi, A., Daniele, G., Giannarelli, D., Tortora, G., & Bria, E. (2023) · EClinicalMedicine · doi:10.1016/j.eclinm.2023.101824 · Cited by 14
Decker, T. W., Lüdtke-Heckenkamp, K., Melnichuk, L., Hirmas, N., Lübbe, K., Zahn, M., Schmidt, M., Denkert, C., Lorenz, R., Müller, V., et al. (2023) · The Breast · doi:10.1016/j.breast.2023.08.007 · Cited by 10
Interstitial lung disease and CDK4/6 inhibitors in the treatment of breast cancer
Schlam, I. M., Giordano, A., & Tolaney, S. M. (2023) · Expert Opinion on Drug Safety · doi:10.1080/14740338.2023.2288147 · Cited by 11
“MONALEESA-2 was a phase 3 trial in which 668 postmenopausal women were randomized to first-line treatment with letrozole with or without ribociclib [14].”
BackgroundLai, J., Kuo, T.-H., Huang, K., Chai, L. M. X., Lee, M., Liu, C., Tsai, Y., Huang, C., Tseng, L., Hsu, C., et al. (2023) · The Oncologist · doi:10.1093/oncolo/oyad304 · Cited by 12
Self-citationMetastatic breast cancer: Endocrine therapy landscape reshaped
Salkeni, M. A., & Hall, S. (2017) · Avicenna Journal of Medicine · doi:10.4103/ajm.ajm_20_17 · Cited by 11
“Compared to placebo, the addition of ribociclib to letrozole significantly improved PFS in the first‐line metastatic settings, in a fashion similar to that of palbociclib.[26] Ribociclib requires a regular monitoring of hepatic transaminases and electrocardiogram as it may be associated with hepatotoxicity and QTc pro…”
Eschbach, R., Kazmierczak, P. M., Heimer, M. M., Todica, A. S., Hirner-Eppeneder, H., Schneider, M. J., Keinrath, G., Solyanik, O., Olivier, J., Kunz, W. G., et al. (2018) · Cancer Imaging · doi:10.1186/s40644-018-0135-y · Cited by 12
“Selective CDK 4/6 inhibition was shown to significantly improve progression-free survival in patients with advanced breast cancer, but to date there are no clinical data on combined BRAF and CDK 4/6 inhibition [11, 26].”
BackgroundMethodCycling Toward Progress: Ribociclib, a CDK 4/6 Inhibitor for Breast Cancer
Spring, L. M., & Bardia, A. (2018) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-18-0463 · Cited by 11
“Regulatory approval of ribociclib was principally based on the Mammary Oncology Assessment of LEE0110s (ribociclib's) Efficacy and Safety (MONALEESA-2) trial (2).”
MethodFernandes, M. T., Adashek, J. J., Barreto, C. M. N., Spinosa, A. C. B., Gutierres, B. D. S., Lopes, G. D. L., Jr., del Giglio, A., & Aguiar, P. N. (2018) · Drugs in Context · doi:10.7573/dic.212555 · Cited by 11
Telford, C., Bertranou, E., Large, S., Phelps, H., Ekman, M., & Livings, C. (2019) · PharmacoEconomics - Open · doi:10.1007/s41669-019-0134-3 · Cited by 11
Li, J., Zhou, Y., Yan, Y., Zheng, Z., Hu, Y., & Wu, W. (2020) · Aging · doi:10.18632/aging.103537 · Cited by 11
Marinelli, O., Romagnoli, E., Maggi, F., Nabissi, M., Amantini, C., Morelli, M. B., Santoni, M., Battelli, N., & Santoni, G. (2020) · BMC Cancer · doi:10.1186/s12885-020-07619-1 · Cited by 11
Preclinical discovery and development of abemaciclib used to treat breast cancer
Wright, M. D., & Abraham, J. (2020) · Expert Opinion on Drug Discovery · doi:10.1080/17460441.2021.1853097 · Cited by 11
“are usually managed via dose reductions or interruptions [47,76].”
BackgroundPreferences of Canadian Patients and Physicians for Treatment of HR+/HER2− Advanced Breast Cancer
Stellato, D., Thabane, M. E., Eichten, C., & Delea, T. E. (2021) · Current Oncology · doi:10.3390/curroncol28010051 · Cited by 12
Targeting transcriptional regulators for treatment of anaplastic thyroid cancer
Lee, W. K. (2021) · Journal of Cancer Metastasis and Treatment · doi:10.20517/2394-4722.2021.58 · Cited by 11
SABR in oligometastatic breast cancer: Current status and future directions
Stewart, R., White, M. A., Tan, J., Siva, S., Karroum, L., & David, S. (2021) · The Breast · doi:10.1016/j.breast.2021.10.009 · Cited by 11
Guillemois, S., Patsouris, A., Peyraga, G., Chassain, K., Corre, Y. L., Campone, M., & Augereau, P. (2018) · Clinical Breast Cancer · doi:10.1016/j.clbc.2018.07.006 · Cited by 11
Self-citationVillacampa, G. J., Falato, C., Paré, L., Hernándo, C., Arumí, M., Saura, C., Melis, G. G., Muñoz-Mateu, M., Gil‐Gil, M., Izarzugaza, Y., et al. (2022) · European Journal of Cancer · doi:10.1016/j.ejca.2022.07.028 · Cited by 11
Arndt, C., Tunger, A., Wehner, R., Rothe, R., Kourtellari, E., Luttosch, S., Hannemann, K., Koristka, S., Loureiro, L. R., Feldmann, A., et al. (2023) · Frontiers in Pharmacology · doi:10.3389/fphar.2023.970457 · Cited by 11
“In particular, the three orally available CDK4/6 inhibitors palbociclib (PD-0332991; Ibrance; Pfizer), ribociclib (LEE011; Kisqali; Novartis) and abemaciclib (LY2835219; Verzenio; Lilly) received approval by the Food and Drug Administration (FDA) for treatment of patients with ER+, human epidermal growth factor recept…”
BackgroundInfluentialZeng, N., Han, J., Liu, Z., He, J., Tian, K., & Chen, N. (2023) · Cancers · doi:10.3390/cancers15133386 · Cited by 10
“The latest studies for the first-line treatment of HR+/HER2− advanced breast cancer (ABC) based on these CDK4/6 inhibitors include the PALOMA series [6–8], the MONARCH series [5], the MONALEESA series [9], and the DAWNA series [10], most of which have achieved positive results.”
BackgroundMethodInfluentialDiscovery of small molecule degraders for modulating cell cycle
Wang, L., Yang, Z., Li, G., Liu, Y., Ai, C., & Rao, Y. (2023) · Frontiers of Medicine · doi:10.1007/s11684-023-1027-5 · Cited by 10
Chen, Z., Liu, X., Kawakami, M., Liu, X., Baker, A. R., Bhatawadekar, A., Tyutyunyk‐Massey, L., Narayan, K., & Dmitrovsky, E. (2023) · Cancer Biology & Therapy · doi:10.1080/15384047.2023.2279241 · Cited by 10
“37,38 Notably, the PLK4 inhibitor CFI-400945 augmented supernumerary centrosomes and suppressed lung cancer cell proliferation by promoting polyploidy and apoptotic death.”
BackgroundBorroni, R. G., Bartolini, M., Gaudio, M., Jacobs, F., Benvenuti, C., Gerosa, R., Tiberio, P., Manara, S. A. A. M., Solferino, A., Santoro, A., et al. (2024) · The Oncologist · doi:10.1093/oncolo/oyae004 · Cited by 10
Cardiovascular complications of ribociclib in breast cancer patients
Fiste, O., Mavrothalassitis, E., Apostolidou, K., Trika, C. O., Liontos, M., Koutsoukos, K., Kaparelou, M., Dimitrakakis, C., Gavriatopoulou, M., Dimopoulos, M. A., et al. (2024) · Critical Reviews in Oncology/Hematology · doi:10.1016/j.critrevonc.2024.104296 · Cited by 11
Miglietta, F., Pontolillo, L., Angelis, C. D., Caputo, R., Mariño, M., Bria, E., Rienzo, R. D., Verrazzo, A., Buonerba, C., Tortora, G., et al. (2024) · The Breast · doi:10.1016/j.breast.2024.103713 · Cited by 10
Moulson, R., Feugère, G., Moreira‐Lucas, T., Dequen, F., Weiss, J., Smith, J. L., & Brezden‐Masley, C. (2024) · Current Oncology · doi:10.3390/curroncol31040161 · Cited by 10
Kimmick, G. G., Pilehvari, A., You, W., Bonilla, G., & Anderson, R. T. (2024) · Breast Cancer Research and Treatment · doi:10.1007/s10549-024-07415-6 · Cited by 15
Elazzazy, S., Al-Ziftawi, N. H., Ibrahim, M. I. M., Bujassoum, S. M., & Hamad, A. A. (2024) · Frontiers in Oncology · doi:10.3389/fonc.2024.1413676 · Cited by 10
Metadata
- Authors
- 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., Janni, W., Verma, S., Conte, P., Arteaga, C. L., Cameron, D. A., Petrakova, K., Hart, L. L., Villanueva, C., Chan, A., Jakobsen, E., Nusch, A., Burdaeva, O., Grischke, E.-M., Alba, E., Wist, E., Marschner, N., Favret, A. M., Yardley, D., Bachelot, T., Tseng, L.-M., Blau, S., Xuan, F., Souami, F., Miller, M., Germa, C., Hirawat, S., & O’Shaughnessy, J.
- Affiliations
- From the University of Texas M.D. Anderson Cancer Center, Houston (G.N.H.), and Texas Oncology–Baylor Charles A. Sammons Cancer Center and the U.S. Oncology Network, Dallas (J.O.) — all in Texas; Davidoff Center, Rabin Medical Center, Tel Aviv University, Tel Aviv (S.M.S.), and Sheba Medical Center, Ramat Gan (S.P.-S.) — both in Israel; the Sarah Cannon Research Institute (H.A.B., D.Y.), Vanderbilt–Ingram Cancer Center (C.L.A.), and Tennessee Oncology (D.Y.) — all in Nashville; National Cancer Center...
- The University of Texas MD Anderson Cancer Center (US)
- Université Paris-Sud (FR)
- Oslo University Hospital (NO)
- Novartis (Switzerland) (CH)
- ORCID
- Stemmer, Salomon M.
- Burris, Howard A.
- Yap, Yoon-Sim
- Sonke, Gabe S.
- Campone, Mario
- Blackwell, Kimberly L.
- André, Fabrice
- Winer, Eric P.
- Janni, Wolfgang
- Verma, Sunil
- Conte, Pierfranco
- Arteaga, Carlos L.
- Cameron, David A.
- Chan, Arlene
- Jakobsen, Erik
- Grischke, Eva-Maria
- Alba, Emilio
- Wist, Erik
- Marschner, Norbert
- Favret, Anne M.
- Yardley, Denise
- Bachelot, Thomas
- Tseng, Ling-Ming
- Blau, Sibel
- Xuan, Fengjuan
- Miller, Michelle
- Germa, Caroline
- O’Shaughnessy, Joyce
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2016-11-03
- Volume
- 375
- Issue
- 18
- Pages
- 1738-1748
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2528767298
- Cited by
- 2,039
- References
- 24
- Citations by year
- 2026: 167 · 2025: 218 · 2024: 203 · 2023: 214 · 2022: 187 · 2021: 247 · 2020: 206 · 2019: 173 · 2018: 237 · 2017: 166 · 2016: 17
- FWCI
- 176.67
- 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) (submittedVersion, other-oa)
- Padua Research Archive (University of Padova) (submittedVersion, other-oa)
- RISalud Institutional Health Repository of Andalucía (submittedVersion, other-oa)
- Funders
- Amgen
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Spectrum Pharmaceuticals
- Celgene
- Exelixis
- Celldex Therapeutics
- TG Therapeutics
- Astex Pharmaceuticals
- Agios Pharmaceuticals
- Jounce Therapeutics
- Mersana Therapeutics
- Incyte
- G1 Therapeutics
- Eisai
- Astellas Pharma
- Ipsen
- Genentech
- Chugai Pharmaceutical
- Novartis Institutes for BioMedical Research
- Loxo Oncology
- 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, CDK4/6 inhibitors, hormone receptor-positive HER2-negative breast cancer, advanced breast cancer, first-line therapy, letrozole, endocrine therapy resistance, progression-free survival, myelosuppression, neutropenia, leukopenia
- MeSH terms
- Letrozole, Adult, Aged, Aged, 80 and over, Aminopyridines, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Double-Blind Method, Drug Administration Schedule, Female, Humans, Middle Aged, Neoplasm Staging, Nitriles, Purines, Receptors, Estrogen, Receptors, Progesterone, Triazoles, Disease-Free Survival, Erb-b2 Receptor Tyrosine Kinases, Kaplan-Meier Estimate
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