FindTrial
Sign In

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)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514205-60-00
Acronym
D5336C00001
Enrollment
3
Registered
2024-08-21
Start date
2018-02-15
Completion date
Unknown
Last updated
2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Triple Negative Breast Cancer

Brief summary

Progression-free Survival Per Stratum (BICR)., Progression-free Survival Per Stratum (Sensitivity Analysis).

Detailed description

Progression-free Survival (Per BICR)., Number of Patients With Objective Response (Per BICR and Per Sensitivity Analysis)., Objective Response Rate (ORR) (Per BICR and Per Sensitivity Analysis), Duration of Response (DoR) [Per BICR and Per Sensitivity Analysis], Percentage Change From Baseline in Target Lesion Tumour Size [Per BICR and Per Sensitivity Analysis], Overall Survival (OS), Plasma Drug Concentrations of olaparib, Plasma Drug Concentrations of ceralasertib and adavosertib, Number of Patients With Treatment Emergent Adverse Events (TEAEs)

Interventions

DRUGAZD6738
DRUGLynparza 150 mg film-coated tablets
DRUGLynparza 100 mg film-coated tablets
DRUGCeralasertib

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Progression-free Survival Per Stratum (BICR)., Progression-free Survival Per Stratum (Sensitivity Analysis).—

Secondary

MeasureTime frame
Progression-free Survival (Per BICR)., Number of Patients With Objective Response (Per BICR and Per Sensitivity Analysis)., Objective Response Rate (ORR) (Per BICR and Per Sensitivity Analysis), Duration of Response (DoR) [Per BICR and Per Sensitivity Analysis], Percentage Change From Baseline in Target Lesion Tumour Size [Per BICR and Per Sensitivity Analysis], Overall Survival (OS), Plasma Drug Concentrations of olaparib, Plasma Drug Concentrations of ceralasertib and adavosertib, Number of Patients With Treatment Emergent Adverse Events (TEAEs)—

Countries

Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026