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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

Monitoring

One Scheduled Monitoring ProvisionSupport & Resources

Summary of Prescibing Information

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MADELINE ASIA Study Limitations1

  • Study limitations included a limited sample size and having only 1 patient receiving PAL+FUL as a second-line treatment.
  • As with all studies that require patients to self-report outcomes and behaviors, completeness and accuracy of reporting may be a concern.

   

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


 

PAL, Palbociclib; FUL, Fulvestrant

   

References:   

Lee KT,et.al. Presented at the Asia Pacific Breast Cancer Summit (APBCS) 2023: May 4-5,2023;Singapore.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, 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®.
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory.
All images used are for representation purposes only
(®)Trademark Proprietor: Pfizer Inc.USA Licensed User: Pfizer Products India Private Limited.India

    

PP-IBR-IND-0626  September 2023

Tolerability/QoL

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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