Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292) - CAPItello-292

Study identifier:D361DC00001

ClinicalTrials.gov identifier:NCT04862663

EudraCT identifier:2020-004637-20

CTIS identifier:N/A

Recruiting

Official Title

A Phase Ib/III, Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)

Medical condition

Locally advanced (inoperable) or Metastatic Breast Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Capivasertib, Fulvestrant, Palbociclib, Ribociclib, Abemaciclib

Sex

All

Estimated Enrollment

895

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 10 May 2021
Estimated Primary Completion Date: 01 Nov 2027
Estimated Study Completion Date: 14 Aug 2029

Study design

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

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria