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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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Trial Design Overview

What were the key features of the PALOMA-3 trial?

   

PALOMA-3 was a randomised, double-blind, placebo-controlled, Phase III study to assess the efficacy of PALBACE® in combination with fulvestrant in premenopausal/perimenopausal and postmenopausal women with HR+/HER2- mBC who had progressed on or after prior ET.1

   

PALOMA-3 Trial Design1

   

   

   

Adapted from Cristofanilli M, et al. 2016.¹

   

   

*Defined as progression during or within 1 month after the end of prior ET in the context of metastatic disease or progression during or within 12 months after discontinuation of adjuvant ET. Overall, 21% of patients had not received prior treatment for their metastatic disease (first line). Premenopausal/Perimenopausal patients received the LHRH agonist goserelin for at least 4 weeks prior to and for the duration of the trial.¹
Sensitivity to prior hormonal therapy was defined as documented clinical benefit (CR, PR or SD ≥24 weeks) to ≥1 prior hormonal therapy regimen in the metastatic setting or ≥24 months of adjuvant hormonal therapy before recurrence.¹
Evaluated according to RECIST version 1.1.1
§ORR was defined as confirmed CR or PR.1
||CBR was defined as CR or PR or SD for ≥24 weeks.1
Premenopausal/Perimenopausal patients received goserelin or an alternative LHRH agonist for at least 4 weeks prior to and for the duration of the trial.1,2

   

AI, aromatase inhibitor; CDK, cyclin-dependent kinase; CNS, central nervous system; CR, complete response; CT, chemotherapy; ECOG, Eastern Cooperative Oncology Group; ET, endocrine therapy; HR+/HER2-, hormone receptor-positive/ human epidermal growth factor receptor 2-negative; IM, intramuscularly; LHRH, luteinising hormone-releasing hormone; mBC, metastatic breast cancer; mTOR, mechanistic target of rapamycin; N, total number of patients; n, number of patients; PFS, progression-free survival; PI3K, phosphoinositide 3-kinase; PR, partial response; RECIST, Response Evaluation Criteria In Solid Tumours; SD, stable disease.

   

References:

Cristofanilli M, Turner NC, Bondarenko I, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, 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.

Ibrance EPAR public assessment report. November 25, 2016. EMA. 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

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Monitoring

One scheduled monitoring provision

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