Trial Identifiers
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Scientific Title
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
Commercial Sponsor
AstraZeneca
Summary
This study has two cohorts. Cohort A will consist of a lower-risk population, and Cohort B will consist of a higher-risk population. Participants will be allocated to receive 300mg oral olaparib twice daily as monotherapy, or in combination with durvalumab 1500mg via intravenous infusion every 4 weeks for a minimum of 4 and maximum of six 28-day cycles before undergoing definitive surgery. Each participant will undergo definitive surgery, preferably within 6 weeks after receiving the final dose of neoadjuvant olaparib therapy, followed by standard treatment (radiation therapy, systemic therapy as per institutional standards). Participants who achieve pCR at surgery will be allowed to continue on treatment with olaparib in the adjuvant setting in lieu of standard adjuvant systemic therapy, per physician's choice. If the physician chooses adjuvant olaparib, then the total duration of olaparib therapy in the neoadjuvant and adjuvant setting should be 12 cycles.