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Clinical Efficacy & SafetyPALOMA-2Trial Design OverviewPatient Baseline CharacteristicsPFS (Primary Endpoint)OS (Secondary Endpoint)Tumour Control (Secondary Endpoint)PALOMA-3Trial Design OverviewPatient Baseline CharacteristicsPFS (Primary Endpoint)OS (Secondary Endpoint)Tumour Control (Secondary Endpoint)SafetySafety OverviewPooled ARsPooled Laboratory AbnormalitiesPALOMA-2 AEsPALOMA-3 AEsSelected Safety FeaturesPALBACE® Long-term SafetyGI and Liver ToxicitiesEffect of PALBACE®  on QTc IntervalElderly PatientsVisceral Disease PatientsDose Reduction Effect on EfficacyReal-world EvidenceWhat are RWD and RWE?PALBACE® Development and RWDHow Does RWE Differ From RCT Evidence?What Is Meant by RWD and RWE?What Is the Value of RWE?Multiple Ongoing Real-world Studies at Varied Geographic LocationsEffectivenessWhat is the Flatiron Database?What Were the Key Features of P-REALITY?What Are the Characteristics of Patients in P-REALITY?P-REALITY Real-world Progression-free SurvivalP-REALITY Overall SurvivallP-REALITY StrengthsP-REALITY SummaryP-REALITY X OverviewP-REALITY X OS and rwPFSP-REALITY X Subgroup analysis OverviewP-REALITY X:OS and rwPFS in Subgroup(Lung & Liver metastasisTolerability/QoLWhat is the MADELINE Study?What Were the Key Features of the MADELINE Study?What Are the Characteristics Of Patients In MADELINE?MADELINE Physician-reported AEsMADELINE Patient-reported OutcomesMADELINE Study LimitationsMADELINE SummaryMADELINE ASIA OverviewMADELINE ASIA Patient Reported OutcomesMADELINE ASIA SafetyMADELINE ASIA Study LimitationsDosingDosingRecommended Dosing ScheduleRecommended Dose Modifications For AEsMonitoring

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OS (Secondary Endpoint)

In PALOMA-3, PALBACE® in combination with fulvestrant in first line or later doubled mPFS versus placebo + fulvestrant in patients with progression on/after ET.1,2,*   

   

In PALOMA-3, OS results demonstrated a numerical, but non-statistically significant difference in favour of PALBACE®

  

The PALOMA-3 OS final analysis of PALBACE® in combination with fulvestrant in first line or later demonstrated a numerical difference in favour of PALBACE® in combination with fulvestrant versus placebo + fulvestrant that did not reach statistical significance1,2

The difference in median OS with PALBACE® in combination with fulvestrant (not statistically significant)1 was similar to the improvement in mPFS previously seen with the addition of PALBACE® to fulvestrant in PALOMA-31,3  

  

PALOMA-3 OS Kaplan-Meier Curve1,2

  

  

  

Adapted from Turner NC, et al. 20181; Palbace. Local product document. 20212.

Data cut-off date: April 13, 2018. 

  

*Not statistically significant at the prespecified significance level of 0.0235 (1-sided).2
†One-sided P value from the log-rank test stratified by the presence of visceral metastases and sensitivity to prior ET per
randomisation.2

  

CI, confidence interval; ET, endocrine therapy; FUL, fulvestrant; HR, hazard ratio; HR+/HER2-, hormone receptor-positive/human epidermal growth factor receptor 2-negative; mBC, metastatic breast cancer; n, number of patients; OS, overall survival; PLA, placebo.

  

References:

Turner NC, Slamon DJ, Ro J, et al. Overall survival with palbociclib and fulvestrant in advanced breast cancer. N Engl J Med.
2018;379(20):1926-1936.

LPD Palbace( Palbociclib) prescribing document, Pfizer Products India private Limited, version 7.0 LPDPAB062023.

Cristofanilli M, Rugo HS, Im SA, et al. Overall survival (OS) with palbociclib (PAL) + fulvestrant (FUL) in women with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2–) advanced breast cancer (ABC): Updated analyses from PALOMA-3. Presented at: ASCO 2021 Annual Meeting; June 5, 2021; Virtual.

   

Please click the Prescribing Information link to view the safety and adverse events information of PALBACE®.
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(®)Trademark Proprietor: Pfizer Inc.USA Licensed User: Pfizer Products India Private Limited.India

    

PP-IBR-IND-0626  September 2023

PALOMA-3

Real-world Evidence

With RCT data, PALBACE® RWE can help improve the understanding of outcomes in patients with HR+/HER2- mBC

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Dosing

Recommended dosing schedule and dose modifications for AEs

 Learn more Monitoring One scheduled monitoring provision Learn more
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