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
Neoadjuvant Olaparib monotherapy group
18 Years - 130 Years
Endpoint Classification: -
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Verified 01 Nov 2023 by AstraZeneca
No locations available
|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