Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2− Breast Cancer - CAPItello-291

Study identifier:D3615C00001

ClinicalTrials.gov identifier:NCT04305496

EudraCT identifier:2019-003629-78

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2−) Breast Cancer Following Recurrence or Progression On or After Treatment with an Aromatase Inhibitor

Medical condition

Locally advanced (inoperable) or Metastatic Breast Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Fulvestrant, Capivasertib, Placebo

Sex

All

Actual Enrollment

818

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 16 Apr 2020
Primary Completion Date: 15 Aug 2022
Estimated Study Completion Date: 09 Jun 2025

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria