The content of this website has been produced in line with the IBRANCE® Summary of Product Characteristics for Great Britain and Northern Ireland. IBRANCE® (palbociclib) Prescribing Information for Great Britain and Northern Ireland click here. Adverse event reporting information can be found at the bottom of the page.
PALOMA-3 Trial Efficacy Outcomes
Confidence In A Treatment that’s Setting The Standard1-3
- Median PFS data
- Patient Subgroup PFS data
- Median OS data
- Chemotherapy and OS data
- Postmenopausal patient OS data
IBRANCE® + fulvestrant achieved 11.2 months' median PFS vs. 4.6 months with fulvestrant plus placebo (HR=0.497; 95% CI: 0.398-0.620, p<0.0001) in patients with HR+/HER2- advanced breast cancer after a median follow-up of 14.0 months.2
Adapted from Cristofanilli M, et al. ECJ 2018;104:21-31.2
The primary endpoint was investigator-assessed PFS, according to RECIST criteria1
In a population of pre-/peri- and postmenopausal women with HR+/HER2- advanced or metastatic breast cancer who had progressed on previous ET therapy1
Median Overall Survival (Final Protocol-Specified OS Analysis)3
In the final protocol-specified analysis, IBRANCE® plus fulvestrant demonstrated a clinically meaningful (but not statisically important) median OS benefit of 6.9 months in the ITT population after a median follow-up of 44.8 months.3
Adapted from Turner NC, et al. N Engl J Med 2018;379:1926–19363
The primary endpoint was investigator-assessed PFS, according to RECIST criteria1
In a population of pre-/peri- and postmenopausal women with HR+/HER2- advanced or metastatic breast cancer who had progressed on previous ET therapy.1
*One-sided p-value with a prespecified threshold for statistical significance of p=0.0235
Median Overall Survival (Updated, Non-Prespecified OS Analysis)5
In an ad hoc, non-prespecified OS analysis, improvements continued to be observed with IBRANCE® plus fulvestrant over a median follow-up of 73.3 months.5
Adapted from Cristofanill M, et al. 2021. Data cut-off August 2020.5
The primary endpoint was investigator-assessed PFS, according to RECIST criteria1
In a population of pre-/peri- and postmenopausal women with HR+/HER2- advanced or metastatic breast cancer who had progressed on previous ET therapy.1
Post hoc exploratory findings suggest that prior CT in the ABC setting may potentially hinder the OS benefit provided by IBRANCE® plus fulvestrant combination therapy.5
Adapted from Cristofanill M, et al. 2021. Data cut-off August 2020.5
The primary endpoint was investigator-assessed PFS, according to RECIST criteria1
In a population of pre-/peri- and postmenopausal women with HR+/HER2- advanced or metastatic breast cancer who had progressed on previous ET therapy.1
Delay to Chemotherapy3
In PALOMA-3, the median time to first-line subsequent CT was 17.6 months with IBRANCE® + fulvestrant vs. 8.8 months with fulvestrant alone (p<0.001).3
Adapted from Turner NC, et al. N Engl J Med 2018;379:1926–1936. Supplementary Appendix.3
The primary endpoint was investigator-assessed PFS, according to RECIST criteria1
In a population of pre-/peri- and postmenopausal women with HR+/HER2- advanced or metastatic breast cancer who had progressed on previous ET therapy.1
In post-menopausal patients, IBRANCE® + fulvestrant achieved 34.8 months median OS vs. 27.1 months with fulvestrant plus placebo (HR=0.73; 95% CI: 0.57–0.95).3
Adapted from Turner NC, et al. N Engl J Med 2018;379:1926–1936. Supplementary Appendix.3
The primary endpoint was investigator-assessed PFS, according to RECIST criteria1
In a population of pre-/peri- and post-menopausal women with HR+/HER2- advanced or metastatic breast cancer who had progressed on previous ET therapy.1
ABC : Advanced Breast Cancer, AI: Aromatase Inhibitor, CI : Confidence Interval, CT : Chemotherapy, ET : Endocrine Therapy, HR : Hazard Ratio, HR+/ HER2- : Hormone Receptor‑Positive/ Human Epidermal Growth Factor Receptor 2-Negative, ITT : Intention-to-treat, LHRH : Luteinising Hormone-Releasing Hormone, OS : Overall Survival, PFS : Progression-Free Survival, RECIST : Response Evaluation Criteria in Solid Tumors, SmPC : Summary Of Product Characteristics.
- Cristofanilli M, et al. Lancet Oncol 2016;17:425–439.
- Cristofanilli M, et al. ECJ 2018;104:21-31.
- Turner NC, et al. N Engl J Med 2018;379:1926–1936 including supplementary appendix.
- IBRANCE® Summary of Product Characteristics for Great Britain click here. IBRANCE® Summary of Product Characteristics for Northern Ireland click here.
- Cristofanilli M, et al. Abstract 1000. Presented at ASCO, 04–08 June 2021, Chicago, IL, USA.
PALOMA-3 Trial
IBRANCE® + Fulvestrant (Ful) Clinical Trial Results
Clinical Trials
- Clinical Trial results for IBRANCE®
IBRANCE® Clinical Trials PALOMA-2 Trial
PALOMA-3 Trial
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Safety
IBRANCE® safety information and outcomes
IBRANCE® Safety Profile Neutropenia Adverse Event Management
Indication
- IBRANCE® is indicated for the treatment of HR+/HER2- locally advanced or metastatic breast cancer:
- In combination with an aromatase inhibitor; or
- In combination with fulvestrant in women who have received prior ET
In pre- or perimenopausal women, the ET should be combined with a LHRH agonist
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