Study on Olaparib vs. Standard Chemotherapy for Metastatic Breast Cancer with BRCA1/2 Mutations

Inclusion Criteria

• Have a harmful or potentially harmful inherited mutation in the BRCA1 or BRCA2 genes.
• Have breast cancer that has been confirmed by lab tests and has spread to other parts of the body.
• Have previously been treated with anthracycline and taxane drugs, either after surgery or for metastatic cancer.
• May have had platinum-based treatment, as long as the cancer did not progress during that treatment, or if it was given after surgery, at least 12 months must have passed since the last dose.
• If the cancer is hormone receptor-positive (ER/PR positive), must have tried at least one hormone therapy and it did not work, or the doctor believes hormone therapy is not suitable.
• Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have adequate bone marrow, kidney, and liver function.

Exclusion Criteria

• Have previously been treated with a PARP inhibitor.
• Have HER2 positive breast cancer.
• Have had more than two previous chemotherapy treatments for metastatic breast cancer.
• Have untreated or uncontrolled cancer that has spread to the brain.
• Have had another cancer unless it was treated and has been disease-free for more than 5 years, except for certain skin cancers, cervical cancer, or early-stage endometrial cancer.
• Have a known HIV infection.
• Be pregnant or breastfeeding.