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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

Monitoring

One Scheduled Monitoring Provision
Support & Resources

Summary of Prescibing Information

TabletCapsule

Multiple Ongoing Real-world
Studies at Varied Geographic
Locations1-12

    

EHR, electronic health record; IRIS, Ibrance Real World Insights; MADELINE, mobile app diary of everyday life and experiences; POLARIS, Predicting OptimaL cAncer RehabIlitation and Supportive care; PRO, patient-reported outcome; RWD, real-world data; RWE, real-world experience; US, United States.

   

References:

Taylor-Stokes G, Mitra D, Waller J, Gibson K, Milligan G, Iyer S. Treatment patterns and clinical outcomes among patients receiving palbociclib in combination with an aromatase inhibitor or fulvestrant for HR+/HER2-negative advanced/metastatic breast cancer in real-world settings in the US: results from the IRIS study. Breast. 2019;43:22-27.

Waller J, Mitra D, Mycock K, et al. Real-world treatment patterns and clinical outcomes in patients receiving palbociclib for hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer in Argentina: the IRIS study. J Glob Oncol. 2019;5:JGO1800239.

Mycock K, Zhan L, Hart K, et al. Real World Treatment Patterns and Clinical Outcomes Associated with Palbociclib Combination Therapy in Nine European Countries: Results from the IRIS Study. Poster 510 presented at the EBCC Virtual Congress, 02-03 Oct 2020.

Taylor-Stokes G, Zhan L, Mycock KL, Milligan G, Hart K, Mitra D. Real world treatment patterns and clinical outcomes associated with palbociclib combination therapy in five European countries: results from the IRIS study. Poster presented at: ESMO virtual congress 2020; September 17, 2020; Virtual.

Mycock K, Zhan L, Taylor-Stokes G, Milligan G, Mitra D. Real-world palbociclib use in HR+/HER2- advanced breast cancer in Canada: the IRIS study. Curr Oncol. 2021;28(1):678-688. 

Rocque G, Blum JL, Montero A, et al. Quality of life in patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer treated with palbociclib in real-world practice settings. Poster presented at: 2019 San Antonio Breast Cancer Symposium (SABCS); December 10-14, 2019; San Antonio, TX.

Karuturi MS, Garrett A, Blum JL, et al. Pre/Perimenopausal women receiving palbociclib for hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2–) advanced breast cancer (ABC) in a real-world setting: treatment patterns from POLARIS. Poster presented at: 2020 San Antonio Breast Cancer Virtual Symposium (SABCS). December 8-11, 2020; Virtual. 

Harbeck N, Law EH, Ajmera M, et al. Characterizing QT prolongation risk among women with HR+/HER2– advanced or metastatic breast cancer treated in real-world settings in Italy and Germany. Poster presented at: European Society for Medical Oncology (ESMO) Breast Cancer 2019 Congress; May 2-4, 2019; Berlin, Germany. 

Laurentiis MD, Harbeck N, Law EH, et al. Real-world treatment patterns and clinical outcomes among women with HR+/HER2– advanced or metastatic breast cancer treated in real-world settings in Italy and Germany. Poster presented at: the 2019 San Antonio Breast Cancer Symposium (SABCS). December 10-14, 2019. 

DeMichele A, Cristofanilli M, Brufsky A, et al. Comparative effectiveness of first-line palbociclib plus letrozole versus letrozole alone for HR+/HER2- metastatic breast cancer in US real-world clinical practice. Breast Cancer Res. 2021;23(1):37. 

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.

Darden C, Mitra D, McSorley D, Davis K, Band J, Iyer S. Treatment satisfaction in women receiving palbociclib combination therapies for advanced/metastatic breast cancer. Future Oncol. 2019;15(2):141-150.

Kim HS, Lee S, Kim JH. Real-world evidence versus randomized controlled trial: clinical research based on electronic medical records. J Korean Med Sci. 2018;33(34):e213.

   

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

What Are RWD and RWE?

    

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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