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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 SummaryTolerability/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 SummaryDosingDosingRecommended Dosing ScheduleRecommended Dose Modifications For AEsMonitoring

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What Were the Key Features of the MADELINE Study?

MADELINE was one of the first studies to evaluate day-to-day impacts of ABC/mBC and  treatment on patients, outside clinical trials.1

   

The study provides valuable real-world patient experience data to inform patient/physician treatment discussion and decision-making.1

   

Site Characteristics, Treatment Patterns, Patient Characteristics and Study Endpoints1

Study Endpoints Included PRO Assessments and Safety Information1

   
  • Patients received daily reminders to track their pain level, fatigue level and mood    

   

   

Note: The image is for illustrative purposes only.   

   

  • Safety endpoints included the incidence, severity and duration of neutropenia events and other AEs occurring during the study

  • At each cycle, the relationship between all PROs and neutropenia was explored by comparing patients without neutropenia during the study (for the cycle-based PROs) and patients with neutropenia at that time point​​​​​​

   

PRO Data Were Collected at Baseline, and Then at Daily, Weekly and Cycle-based Intervals for 6 Months1

   

   

*SF-12 is a shortened version of the 36-Item Short Form Health Survey for measuring general health status in study populations. The PCS-12 and MCS-12 scale scores were calculated from responses to yield a mean score of 50 and an SD of 10 in the US population; higher scores represented better health. 
CES-D-10 is a 10-item, self-administered questionnaire assessing depression during the past week. The 10 items are rated on a 4-point scale and summed to produce a total score, ranging from 0 to 30. A total score of 10 or more is considered indicative of depression.
0 being no pain or fatigue and 10 being the worst possible pain or fatigue. Daily ratings for pain and fatigue were averaged to create respective weekly scores. 
§1 = Not at all; 2 = A little; 3 = Moderately; 4 = Quite a bit; 5 = A great deal.

   

ABC, advanced breast cancer; AE, adverse event; AI, aromatase inhibitor; CES-D-10, 10-item center for epidemiological studies depression scale; eCRF, electronic case report form; HR+/HER2-, hormone receptor-positive/human epidermal growth factor receptor 2-negative;  MADELINE, mobile app diary of everyday life and experiences; mBC, metastatic breast cancer; MCS-12, mental component summary; NRS, numeric rating scale; PCS-12, physical component summary; PRO, patient-reported outcome; QoL, quality of life; SD, standard deviation; SF-12, 12-item Short Form Health Survey; US, United States.   

   

 Reference:

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.

   

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.

    

PP-IBR-IND-0462 27 July 2022

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

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