Adjuvant Palbociclib for Early Breast Cancer: The PALLAS Trial Results (ABCSG-42/AFT-05/BIG-14-03)
Open accessAbstract
PURPOSE: Palbociclib is a cyclin-dependent kinase 4 and 6 inhibitor approved for advanced breast cancer. In the adjuvant setting, the potential value of adding palbociclib to endocrine therapy for hormone receptor–positive breast cancer has not been confirmed. PATIENTS AND METHODS: In the prospective, randomized, phase III PALLAS trial, patients with hormone receptor–positive, human epidermal growth factor receptor 2–negative early breast cancer were randomly assigned to receive 2 years of palbociclib (125 mg orally once daily, days 1-21 of a 28-day cycle) with adjuvant endocrine therapy or adjuvant endocrine therapy alone (for at least 5 years). The primary end point of the study was invasive disease-free survival (iDFS); secondary end points were invasive breast cancer–free survival, distant recurrence-free survival, locoregional cancer-free survival, and overall survival. RESULTS: Among 5,796 patients enrolled at 406 centers in 21 countries worldwide over 3 years, 5,761 were included in the intention-to-treat population. At the final protocol-defined analysis, at a median follow-up of 31 months, iDFS events occurred in 253 of 2,884 (8.8%) patients who received palbociclib plus endocrine therapy and in 263 of 2,877 (9.1%) patients who received endocrine therapy alone, with similar results between the two treatment groups (iDFS at 4 years: 84.2% v 84.5%; hazard ratio, 0.96; CI, 0.81 to 1.14; P = .65). No significant differences were observed for secondary time-to-event end points, and subgroup analyses did not show any differences by subgroup. There were no new safety signals for palbociclib in this trial. CONCLUSION: At this final analysis of the PALLAS trial, the addition of adjuvant palbociclib to standard endocrine therapy did not improve outcomes over endocrine therapy alone in patients with early hormone receptor–positive breast cancer.
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Consistent differences in outcomes (OS and IDFS) have emerged across phase III studies of CDK4/6 inhibitors.
“consistent differences in outcomes (OS and IDFS) have emerged across phase III studies of these therapies”
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 [22]
Palbociclib, in contrast to abemaciclib and ribociclib, has not shown a clinically meaningful or statistically significant difference in OS in the first- or second-line ABC setting or an invasive disease-free survival (IDFS) benefit in the EBC setting.
“which in contrast to abemaciclib and ribociclib, has not shown a clinically meaningful or statistically significant difference in OS in the firstor second-line ABC setting or an invasive disease-free survival (IDFS) benefit in the EBC setting.17,18,21,22”
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 [22]
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The Evolving Pathways of the Efficacy of and Resistance to CDK4/6 Inhibitors in Breast Cancer
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The Role of CD4/6 Inhibitors in Breast Cancer Treatment
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Oral Maintenance Therapy in Early Breast Cancer—How Many Patients Are Potential Candidates?
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- Authors
- Gnant, M., Dueck, A. C., Frantal, S., Martin, M., Burstein, H. J., Greil, R., Fox, P., Wolff, A. C., Chan, A., Winer, E. P., Pfeiler, G., Miller, K. D., Colleoni, M., Suga, J. M., Rubovsky, G., Bliss, J. M., Mayer, I. A., Singer, C. F., Nowecki, Z., Hahn, O., Thomson, J., Wolmark, N., Amillano, K., Rugo, H. S., Steger, G. G., Hernando Fernández de Aránguiz, B., Haddad, T. C., Perelló, A., Bellet, M., Fohler, H., Metzger Filho, O., Jallitsch-Halper, A., Solomon, K., Schurmans, C., Theall, K. P., Lu, D. R., Tenner, K., Fesl, C., DeMichele, A., Mayer, E. L., & on behalf of the PALLAS groups and investigators
- Affiliations
- Comprehensive Cancer Center Vienna (AT)
- Mayo Clinic (US)
- Austrian Breast & Colorectal Cancer Study Group (AT)
- Hospital General Universitario Gregorio Marañón, Madrid, Spain
- Dana-Farber Cancer Institute (US)
- Paracelsus Medical University (AT)
- Government of New South Wales (AU)
- Johns Hopkins University (US)
- Curtin University (AU)
- Indiana University Health (US)
- European Institute of Oncology (IT)
- Kaiser Permanente Vallejo Medical Center (US)
- National Institute of Oncology, Budapest, Hungary
- Institute of Cancer Research (GB)
- Vanderbilt University Medical Center (US)
- The Maria Sklodowska-Curie National Research Institute of Oncology (PL)
- University of Chicago (US)
- Peninsula Health (AU)
- University of Pittsburgh (US)
- Hospital Universitari Sant Joan de Reus (ES)
- University of California, San Francisco (US)
- GEICAM Spanish Breast Cancer Group, Madrid, Spain
- Hospital Universitario Son Espases (ES)
- Vall d'Hebron Institute of Oncology (ES)
- Alliance Foundation Trials (US)
- BIG, Brussels, Belgium
- Pfizer (United States) (US)
- University of Pennsylvania (US)
- GEICAM – Spanish Breast Cancer Group (ES)
- ORCID
- Gnant, Michael
- Dueck, Amylou C.
- Martin, Miguel
- Greil, Richard
- Fox, Peter
- Wolff, Antonio C.
- Chan, Arlene
- Winer, Eric P.
- Pfeiler, Georg
- Miller, Kathy D.
- Colleoni, Marco
- Suga, Jennifer M.
- Rubovsky, Gabor
- Bliss, Judith M.
- Mayer, Ingrid A.
- Singer, Christian F.
- Nowecki, Zbigniew
- Thomson, Jacqui
- Wolmark, Norman
- Amillano, Kepa
- Rugo, Hope S.
- Steger, Guenther G.
- Hernando Fernández de Aránguiz, Blanca
- Haddad, Tufia C.
- Perelló, Antonia
- Bellet, Meritxell
- Metzger Filho, Otto
- Schurmans, Céline
- Lu, Dongrui R.
- Tenner, Kathleen
- Fesl, Christian
- DeMichele, Angela
- Mayer, Erica L.
- Venue
- Journal of Clinical Oncology
- Published
- 2022-01-20
- Volume
- 40
- Issue
- 3
- Pages
- 282-293
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- PMC
- PMC10476784
- OpenAlex
- W4200066800
- Cited by
- 235
- References
- 46
- Citations by year
- 2026: 26 · 2025: 70 · 2024: 56 · 2023: 51 · 2022: 32
- FWCI
- 22.57
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- IUScholarWorks (Indiana University) (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Funders
- Pfizer
- Cancer Research UK (25351)
- National Institute for Health and Care Research (NIHR202432)
- National Cancer Institute (U10CA180868, R01CA214893)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › 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
- palbociclib, early breast cancer, hormone receptor-positive breast cancer, HER2-negative breast cancer, adjuvant therapy, endocrine therapy, invasive disease-free survival, PALLAS trial
- MeSH terms
- Progression-Free Survival, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Female, Humans, Mastectomy, Middle Aged, Neoplasm Staging, Piperazines, Prospective Studies, Pyridines, Time Factors, Chemotherapy, Adjuvant, Disease Progression, Disease-Free Survival, Antineoplastic Agents, Hormonal, Neoadjuvant Therapy, Protein Kinase Inhibitors
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