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DosingDosingIBRANCE® Dosing
 
Monitoring Requirements
SafetySafetyIBRANCE® Safety ProfileNeutropeniaAdverse Event ManagementClinical Trials
Clinical TrialsIBRANCE® Clinical TrialsIBRANCE® PALOMA-2 Trial
 
IBRANCE® PALOMA-3 Trial
Real World EvidenceReal World EvidenceIBRANCE® Real World EvidenceIRIS (UK) StudyROIS
 
P-REALITY X
Patient ProfilesThe Ibrance® PatientPatient ProfilesAlison - >65 years with comorbiditiesBecky - Postmenopausal with bone-only diseaseSupport and ResourcesSupport and ResourcesIBRANCE Service SupportMaterials
 
Videos

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

Median Progression-Free Survival

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

Median Overall Survival in Patients Who Received Prior Chemotherapy For ABC5

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

Overall Survival in Patient Subgroups: Post-menopausal Patients3

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.

References

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.
PP-IBR-GBR-3574. May 2022
PALOMA-3 TrialClinical TrialsSafety IndicationIBRANCE® 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

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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