Study identifier:D931CC00001
ClinicalTrials.gov identifier:NCT05498155
EudraCT identifier:2021-005231-22
CTIS identifier:N/A
A Phase II, Multicentre, Open-Label Study to Assess the Efficacy and Safety of Olaparib Monotherapy and Olaparib Plus Durvalumab Combination as Neoadjuvant Therapy in Patients with BRCA Mutations and Early Stage HER2-Negative Breast Cancer
Breast Cancer
Phase 2
No
Neoadjuvant Olaparib monotherapy group, Neoadjuvant combination therapy with olaparib plus durvalumab
All
56
Interventional
18 Years - 130 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 May 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Cohort A Cohort A will consist of a lower-risk population of participants with HER2-negative ER-negative or ER-low defined as having a tumour size >5 mm and ≤20 mm and N0 (T1b-c/N0). | Drug: Neoadjuvant Olaparib monotherapy group Neoadjuvant olaparib monotherapy (300 mg BID) for four to six 28-day cycles. Other Name: Cohort A |
Experimental: Cohort B Cohort B will consist of a higher-risk population of participants with HER2-negative ER-negative or ER-low defined as having a tumour size of >20 mm but ≤50 mm and N0 (T2/N0), or having a tumour size of >1 mm but ≤20 mm and N1 (T1/N1). | Combination Product: Neoadjuvant combination therapy with olaparib plus durvalumab Neoadjuvant combination therapy with olaparib (300 mg BID) plus durvalumab (1500 mg IV Q4W) for four to six 28-day cycles. Other Name: Cohort B |