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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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Tumour Control (Secondary Endpoint)

In PALOMA-2, PALBACE® in combination with letrozole improved tumour response in postmenopausal women

    

PALBACE® in combination with letrozole improved tumour response versus placebo + letrozole in first line and within the visceral subgroups.1,2

   

PALOMA-2 Tumour Response1

   

   

In patients with visceral metastasis who are naïve to ET in the advanced disease setting, ORR was 55.1% for PALBACE® in combination with letrozole (n=214) versus 40% with placebo + letrozole (n=110).2 

Adapted from Finn RS, et al. 2016.1
​​​​​​​

Data cut-off date: 26 February 2016.1

   

   

*Defined as confirmed CR or PR.2 

†Defined as confirmed CR, PR or SD for ≥24 weeks.1 

   

CBR, clinical benefit rate; CR, complete response; ET, endocrine therapy; ITT, intention to treat; LET, letrozole; n, number of patients; ORR, objective response rate; PLA, placebo; PR, partial response; SD, stable disease.

   

References:

Finn RS, Martin M, Rugo HS, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375(20):1925-1936.

Turner NC, Finn RS, Martin M, et al. Clinical considerations of the role of palbociclib in the management of advanced breast cancer patients with and without visceral metastases. Ann Oncol. 2018;29(3):669-680.

   

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

PALOMA-2

Real-world Evidence

With RCT data, PALBACE® RWE can help improve the understanding of outcomes in patients with HR+/HER2- mBC

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Dosing

Recommended dosing schedule and dose modifications for AEs

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