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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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MADELINE Physician-reported AEs1

  • A total of 840 AEs were recorded among 96 patients (69%)
  • Overall, 12 patients experienced at least 1 SAE, with a total of 35 SAEs reported
  

AEs Reported in ≥15% of Evaluable Patients (n=139)*

    

SAEs Reported (n=139)*     

    

    

Adapted from Richardson D, et al. 2021.1

    

Overall, 45% of patients (n=62) experienced a neutropenia event1,*

  • Overall, 152 neutropenia events were reported among 62 patients, and 3 febrile neutropenia events were experienced among 3 patients
  • Only 11% and 16% of patients required dose adjustments and treatment interruptions, respectively, due to neutropenia  

Patients With Neutropenia Onset by Cycle

   

   

Adapted from Richardson D, et al. 2021.1

   

Neutropenia severity experienced*

   

Adapted from Richardson D, et al. 2021.1

   

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 

   

*As graded by investigators per CTCAE.   

   

AE, adverse event; AI, aromatase inhibitor; CTCAE, Common Terminology Criteria for Adverse Events; FUL, fulvestrant; N, total number of patients; n, number of patients; SAE, serious adverse event.

   

References:

Richardson D, Zhan L, Mahtani R, et al. A prospective observational study of patient-reported functioning and quality of life in advanced and metastatic breast cancer utilizing a novel mobile application. Breast Cancer Res Treat. 2021;187(1):113-124.

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®.
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(®)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

 Learn more

   

Dosing

Recommended dosing schedule and dose modifications for AEs

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Monitoring One scheduled monitoring provision Learn more
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