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).
Metastatic Triple Negative Breast Cancer
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).
18 Years - 130 Years
Endpoint Classification: -
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Verified 01 Sept 2023 by AstraZeneca
No locations available
|Active Comparator: Olaparib monotherapy|
All randomized patients will receive Olaparib monotherapy 300 mg twice daily (BD).
Drug: Olaparib Continuous (28-Day cycle) 300 mg BD.
Two (2) 150 mg olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water (approximately 250 mL).
|Active Comparator: Olaparib+Ceralasertib|
All randomized patients will receive Olaparib 300 mg twice daily+Ceralasertib 160 mg once daily (OD).
Drug: Ceralasertib 160 mg OD + olaparib continuous 300 mg BD (28-day cycle).
Patients will be administered Ceralasertib OD at 160 mg from Day 1 to Day 7 (inclusive) of every 28-day cycle.
|Active Comparator: Olaparib+adavosertib|
All randomized patients will receive Olaparib 200 mg BD +adavosertib 150 mg BD. Following the discontinuation of adavosertib+olaparib treatment arm on 18 April 2019, patients receiving treatment with adavosertib+olaparib treatment were offered the opportunity to continue treatment on olaparib monotherapy at the approved dose (300 mg bd).
Drug: Adavosertib 150 mg BD + olaparib 200 mg BD (21-day cycle).
Patients will be administered adavosertib BD at 150mg from Day 1 to Day 3 and Day 8 to Day 10.