A Phase Ib/III Randomised Study of Capivasertib plus Palbociclib and Fulvestrant versus Placebo plus Palbociclib and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer

Status

Active (Non-Recruiting)

Disease

hormone receptor-positive (HR+), HER2-negative locally advanced, unresectable, or metastatic breast cancer.

Treament Agent

Capivasertib + Palbociclib + Fulvestrant

Study Phase

Phase III

Resources and Links

https://www.clinicaltrials.gov/study/NCT04862663

Physician Name(s)

Dr Mastura Md Yusof

Datuk Dr Lam Kai Seng

Description

This Phase Ib/III study (CAPItello-292) evaluates the efficacy, safety, and added benefit of combining capivasertib with CDK4/6 inhibitors (CDK4/6i) and fulvestrant in patients with locally advanced or metastatic HR+/HER2- breast cancer. The Phase Ib part will determine the recommended doses for the triplet combination, while the Phase III part will compare the triplet regimen (capivasertib + CDK4/6i + fulvestrant) with the control arm (fulvestrant + CDK4/6i) in high-risk patients who haven't received prior endocrine therapy in the advanced setting.

Cancer Type

Breast Cancer

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