Palbociclib Pfizer

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HomeAboutMode of actionEfficacyPALOMA-2Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)PALOMA-3Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)Real World EvidenceP-REALITY study designP-REALITY patients characteristicsP-REALITY real-world progression-free survivalP-REALITY overall survivalP-REALITY strengthsSafetyImportant Safety InformationSafetySafety overviewPooled ARsPooled laboratory abnormalitiesPALOMA-2 AEsPALOMA-3 AEsSelected safety featuresPalbociclib long-term safetyGI and liver toxicitiesEffect of Palbociclib on QTc intervalElderly patientsVisceral disease patientsDose reduction effect on efficacyDosingRecommended dosing scheduleRecommended dose modifications for AEsOne scheduled monitoring provisionMedical InformationVisit the Pfizer Medical Information Africa Website for Healthcare ProfessionalsSubmit a medical question to Pfizer

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Trial design overview

PALOMA-3 was a randomised, double-blind, placebo-controlled, Phase III study to assess the efficacy of Palbociclib Pfizer in combination with fulvestrant in pre-/peri- and post-menopausal women with HR+/HER2- mBC who had progressed on or after prior ET1

PALOMA-3 Trial Design1Adapted from Cristofanilli M, et al. 2016.¹
Defined as progression during or within 1 month after the end of prior ET in the context of metastatic disease or progression during or within 12 months after discontinuation of adjuvant ET. 21% of patients had not received prior treatment for their metastatic disease (1st line). Pre-/peri-menopausal patients received the LHRH agonist goserelin for at least 4 weeks prior to and for the duration of the trial.¹ Sensitivity to prior hormonal therapy was defined as documented clinical benefit (CR, PR, or SD ≥24 weeks) to ≥1 prior hormonal therapy regimen in the metastatic setting or ≥24 months of adjuvant hormonal therapy before recurrence.¹
Evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.1 ORR was defined as confirmed CR or PR.1CBR was defined as CR or PR or SD for ≥24 weeks.1​​​​​​​ Adapted from Cristofanilli M, et al. 2016.¹Pre-/peri-menopausal patients received goserelin or an alternative LHRH agonist for at least 4 weeks prior to and for the duration of the trial.1,2Explore More PALOMA-2

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AI = aromatase inhibitor; CDK = cyclin-dependent kinase; CNS = central nervous system; CR = complete response; CT = chemotherapy; ECOG = Eastern Cooperative Oncology Group; ET = endocrine therapy; HR+/HER2- = hormone receptor-positive, human epidermal growth factor receptor 2-negative; IM = intramuscularly; LHRH = luteinising hormone-releasing hormone; mBC = metastatic breast cancer; mTOR = mechanistic target of rapamycin; N/n = number of patients; PI3K = phosphoinositide 3-kinase; PFS= progression-free survival; PR = partial response; RECIST = Response Evaluation Criteria In Solid Tumors; SD = stable disease.References:Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-439.
Palbociclib Pfizer EPAR Public assessment report.
PALOMA-3

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