A phase II, randomised, non-comparative two-arm trial of neoadjuvant chemotherapy plus either olaparib or olaparib + durvalumab in young, pre-menopausal women with HRD-enriched, HR-positive, HER2-negative early breast cancer (BCT 2301 OLIO).

Full description

THIS DATASET IS NOT YET AVAILABLE FOR SHARING. Dataset of 56 young (18-44 years), pre-menopausal women with HRD-enriched, HR-positive, HER2-negative early breast cancer. OLIO is a non-comparative randomised clinical trial evaluating the pCR rate of olaparib + paclitaxel, with or without durvalumab, in HRD-positive breast cancer patients. The primary focus is to assess whether any of the two treatment arms have an acceptable pCR rate. All comparisons between the arms are purely exploratory to inform the design of a subsequent trial. Participants will have standard neoadjuvant treatment of 4 cycles anthracycline-based chemotherapy, followed by 12 weeks of study treatment. Arm A: Olaparib: 100 mg tablet taken twice daily for weeks 1-12 with weekly paclitaxel intravenously (IV) 80 mg/m^2 for 12 weeks. Arm B: Olaparib: 100 mg tablet taken twice daily for weeks 1-12; and Durvalumab: 1500 mg intravenously (IV) every 4 weeks for 12 weeks (i.e. 3 treatments) with weekly paclitaxel intravenously (IV) 80 mg/m^2 for 12 weeks. Participants will be followed up for 5 years after surgery. Cancer Australia demographic data has been collected including: Year of birth, Postcode of home of address, Ethnicity, CALD status (Country of Birth, Main language spoken as a child, Main language other than English used as the principle means of communication).

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