Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy.
The purpose of this study is to compare the addition of olaparib after the usual care of chemotherapy, surgery, and radiation for your type of cancer. In this study, you will get either olaparib or placebo, a pill that looks like the study drug but contains no medication. The use of olaparib could reduce the risk of your cancer coming back but it could also cause side effects.
To be better than placebo, the olaparib should decrease the chance of cancer coming back as compared to the placebo. More than 2000 patients suffering from a variety of cancers have already taken olaparib at different doses, either on its own or with another chemotherapy drug. Olaparib is experimental and not approved by the Food and Drug Administration (FDA) for use in any type of cancer.
As of October 2013 about 248 patients with advanced breast cancer have been treated with olaparib. There will be about 1320 people world-wide taking part in this study.
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