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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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P-REALITY X:OS &rwPFS in Subgroup(Lung & Liver metastatsis)1

PAL + AI demonstrated significantly prolonged OS and rwPFS (sIPTW: HR = 0.64; P<0.001 and HR=0.57; P<0.001, respectively) in mBC patients with lung and liver metastases, supporting the use of 1L Pal + AI for patients with HR+/HER2-mBC with visceral metastatic diseases1


*OS was defined as the time in months from the index date to death from any cause. †rwPFS was defined as the number of months from index date to the date of the first documentation of real-world
progressive disease or death due to any cause, whichever occurred first.
 

 

Observational retrospective analyses are designed to evaluate associations among variables and cannot establish causality. Observational retrospective analyses are not intended for direct comparison with clinical trials.2,3 



HR+/HER2- MBC: Hormone Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative Metastatic Breast Cancer; Pal: Palbociclib; AI: Aromatase Inhibitor; 1L: First-Line; n: No. of Patients; OS: Overall Survival; rwPFS: real-world Progression-Free Survival; sIPTW: stabilized Inverse-Probability Treatment Weighting; PSM: Propensity Score Matching; HR: Hazard Ratio; CI: Confidence Interval.

 

   

   

References:   

Brufsky A, et al. ESMO 2023; Abstract 223P.Gerstein HC, McMurray J, Holman RR. Real-world studies no substitute for RCTs in establishing efficacy. Lancet. 2019;393(10168):210-211.Corrigan-Curay J, et al. JAMA. 2018;320(9):867-868. Corrigan-Curay J, Sacks L, Woodcock J. Real-world evidence and real-world data for evaluating drug safety and effectiveness. JAMA.
2018;320(9):867-868.

   

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

Effectiveness

Patient-reported Outcomes

Impact of PALBACE® in combination with another drug on patients’ QoL

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Clinical Efficacy & Safety

PALOMA was the first clinical trial programme to explore how a CDK4/6 inhibitor could benefit women with HR+/HER2- mBC

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Dosing

Recommended dosing schedule and dose modifications for AEs

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Monitoring One scheduled monitoring provision Learn more
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