To assess Safety and Efficacy of Agents Targeting DNA Damage Repair with Olaparib versus Olaparib Monotherapy.

Study identifier:D5336C00001

ClinicalTrials.gov identifier:NCT03330847

EudraCT identifier:2017-002361-22

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase II, Open Label, Randomised, Multi-centre Study to Assess the Safety and Efficacy of Agents Targeting DNA Damage Repair in Combination with Olaparib versus Olaparib Monotherapy in the Treatment of Metastatic Triple Negative Breast Cancer Patients Stratified by Alterations in Homologous Recombinant Repair (HRR)-related Genes (including BRCA1/2) (VIOLETTE).

Medical condition

Metastatic Triple Negative Breast Cancer

Phase

Phase 2

Healthy volunteers

No

Study drug

Olaparib Continuous (28-Day cycle) 300 mg BD., Ceralasertib 160 mg OD + olaparib continuous 300 mg BD (28-day cycle)., Adavosertib 150 mg BD + olaparib 200 mg BD (21-day cycle).

Sex

All

Actual Enrollment

273

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 07 Mar 2018
Primary Completion Date: 13 Nov 2020
Estimated Study Completion Date: 30 Sept 2024

Study design

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

Verification:

Verified 01 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria