The EMBRACE study: This Phase II trial is evaluating an oral drug (Olaparib) in the treatment of HR-deficient metastatic breast cancer and relapsed ovarian cancer without BRCA1 and BRCA2 mutationsPhase II clinical trial of the PARP inhibitor, olaparib, in HR-deficient metastatic breast and relapsed ovarian cancer in patients without germline mutations in BRCA1 and BRCA2

Summary

Olaparib is the study intervention in this trial. Olaparib (LynparzaTM) is a poly(ADP-ribose) polymerase (PARP) inhibitor. The inactive ingredients are copovidone, colloidal silicon dioxide, mannitol, sodium stearyl fumarate, hydroxypropyl methylcellulose (hypromellose), macrogol 400 (polyethylene glycol 400), titanium dioxide, iron oxide yellow and iron oxide black. It is provided as tablets each containing 100mg or 150mg olaparib for oral administration. administered as 300 mg orally twice daily until disease progression or unacceptable toxicity. Each bottle contains 32 tablets. Patients will be asked to return unused drug and empty drug containers at each return visit for adherence. Olaparib should be commenced within 7 days after registration and will be continued until disease progression or unacceptable toxicity.