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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 ASIA Overview

Madeline Asia: A smartphone-application-based, prospective, observational study of patient-reported outcomes and quality of life  for people with HR+/HER2- advanced breast cancer receiving Palbociclib + Aromatase Inhibitor in Asia1 

Objective:

 

  • To assess  patient-reported outcomes(PROs) in women with HR+/HER2- ABC/mBC starting palbociclib (PAL) + endocrine therapy (ET) via a smartphone-based application (app) in a real-world setting.

STUDY  DESIGN:

 

  • Women aged ≥ 18 years and receiving PAL + AI as first-line ET or PAL + fulvestrant(FUL) as second-line ET  for the treatment  of HR+/HER2- ABC /mBC were enrolled  between February 2020 and december 2021 from 4 regions(Hong Kong, India, Malaysia, Taiwan).
  • Enrolled patients were provided access to, and trained on the use of, a smartphone app to complete daily, weekly, and/or monthly/cycle based assessments for  a period of 6 months. 
  • Information on AEs was collected on electronic case-report forms.


PATIENT REPORTED OUTCOMES:

 

  • Two PRO questionnaries were used: 1. 12-item Short Form Health Survey(SF-12); 2. 10-item Center for Epidemiological  Studies - Depression Scale (CES-D-10) .
  • Targeted PRO items included  questions on pain and fatigue (scored  on a scale of 0[best] to 10[worst]), mood, interference on life by the breast cancer  or its traetment , time missed from work, overall health rating, and quality of life, and patient satisfaction with treatment.  
     


Baseline demographic and clinical characteristics:
 
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 

   

Data may not add up to 100% due to missing values.  
aAdditional other disease site included chest wall, neck, pleura ,spine, left axillary lymph node, left adrenal gland, left supraclavicular node, neuroendocrine carcinoma, peritoneal, right, axillary lymphadenopathy, right internal mammary lymph node, skin, and thyroid.
bVisceral sites included brain, liver, lung, left adrenalgland, neuroendocrine carcinoma, peritoneal, pleura, apine and thyroid. 
cNon-Visceral sites included bone, breast, chest wall, left axillary lymph nodes, left, supraclavicular node, lymph node, neck, right axillary lymphadenopathy, right internal mammary lymph  node, and skin.  


HR+/HER2-:Harmone Receptor Positive, Human Epidermal Growth factor Receptor 2 Negative; ABC: Advanced Breast Cancer; mBC: metastatic  Breast Cnacer; AEs: Adverse Events; PAL: Palbociclib AI:Aromatase Inhibitor; ECOG:Eastern Cooperative Oncology Group    

   

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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