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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
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Summary of Prescibing Information

TabletCapsule

PFS (Primary Endpoint)

PALOMA-3 PFS

   

In PALOMA-3, PALBACE® in combination with fulvestrant in first line or later doubled mPFS versus placebo + fulvestrant in patients with progression on/after ET.1,2,*

   

PALOMA-3 PFS* Kaplan-Meier Curve1,2

   

In a randomised (in the ratio of 2:1), double-blind, Phase III trial of women with HR+/HER2- mBC whose disease progressed following ET (N=521)2

   

   

lmprovement in PFS Was Seen Across a Broad Range of Patients

   

PALBACE® in combination with fulvestrant reduced the risk of disease progression versus placebo + fulvestrant in multiple predefined patient subpopulations.2,3

   

Subgroups included:   

  • premenopausal/perimenopausal women
  • Elderly patients (≥65 years)
  • Patients with visceral metastases
    Download the chart

   

Adapted from PALBACE EPAR public assessment report.3

   

Data cut-off: 23 October 2015.

   

   

*Evaluated according to RECIST Version 1.1.2
Data cut-off date: 16 March 2015.
Updated non-prespecified analysis.
§Visceral metastasis was defined as lung, liver, brain, pleural or peritoneal involvement.2
||Sensitivity to prior hormonal therapy is defined as either a) documented clinical benefit (i.e. CR, PR or SD ≥24 weeks) to at least 1
prior hormonal therapy in the metastatic setting or b) at least 24 months of adjuvant hormonal therapy prior to recurrence.3

DFI is time from diagnosis of primary breast cancer to first relapse in patients who received adjuvant therapy.3
**AI: anastrozole, letrozole or exemestane.
††Anti-oestrogen: tamoxifen, tamoxifen citrate, toremifene or toremifene citrate.
‡‡Other: neither an AI nor an anti-oestrogen.

   

CI, confidence interval; CR, complete response; ECOG PS, Eastern Oncology Cooperative Group performance status; ET, endocrine therapy; FUL, fulvestrant; HR, hazard ratio; HR+/HER2-, hormone receptor-positive/human epidermal growth factor receptor 2-negative; ITT, intention to treat; mBC, metastatic breast cancer; mPFS, median progression-free survival; n, number of patients; PFS, progression-free survival; PLA, placebo; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumours; SD, standard deviation.

   

References:

Palbace. Local product document. Pfizer; 2021. Version LPDPAB102021.

Cristofanilli M, Turner NC, Bondarenko I, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptorpositive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial [published correction appears in Lancet Oncol. 2016;17(4):e136] [published correction appears in Lancet Oncol. 2016;17(7):e270]. Lancet Oncol. 2016;17(4):425-439.

Palbace EPAR public assessment report. November 25, 2016. Accessed May 2, 2022.
https://www.ema.europa.eu/en/documents/assessment-report/ibrance-epar-public-assessment-report_en.pdf

   

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

PALOMA-3

   

Real-world Evidence

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

Learn more

   

Dosing

Recommended dosing schedule and dose modifications for AEs

Learn more

   

Monitoring

One scheduled monitoring provision

Learn more
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