Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC - CAPItello-290

Study identifier:D3614C00001

ClinicalTrials.gov identifier:NCT03997123

EudraCT identifier:2018-004687-64

CTIS identifier:2023-505009-17-00

Recruitment Complete

Official Title

A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib/+Paclitaxel vs Placebo+Paclitaxel as First-line Treatment for Patients With Locally Advanced (Inoperable) or Metastatic TNBC.

Medical condition

Triple Negative Breast Neoplasms

Phase

Phase 3

Healthy volunteers

No

Study drug

Capivasertib, Paclitaxel, Placebo

Sex

All

Actual Enrollment

923

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 25 Jun 2019
Estimated Primary Completion Date: 21 Feb 2025
Estimated Study Completion Date: 21 Feb 2025

Study design

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

Verification:

Verified 01 Oct 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria