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Contact: AstraZeneca Clinical Study Information Center by email or phone: 1-877-240-9479.
The purpose of this study is to learn the safety and effectiveness of the PARP inhibitor, olaparib as a single drug therapy compared with olaparib in combination with the new agent AZD6738 in patients with metastatic Triple-Negative Breast Cancer (TNBC).
This is a randomized, two-arm, open label study.
This is a randomized study, which means that participants will be placed into one of the two treatment groups by chance. Neither patients nor the research doctor will choose the group participants are placed in.
The study has two arms. This means that patients in the study are placed in one of two different groups. One group will received the PARP inhibitor olaparib only and the other group will receive olaparib and AZD6738.
The study is open-label. All participating patients will know which group they have been assigned to.
Participants will have tumor biomarker testing to look for mutations in genes that called "homologous recombination repair" (HRR) pathway genes. Participants will be divided into three groups based on their tumor biomarker test results:
Eligible patients will be randomly placed in one of two treatment arms:
Participants will stay on the study until they have progression of their cancer or an adverse event that requires them to end their participation. Participants will be followed for up to 24 months.
NOTE: Additional study sites can be found on clinicaltrials.gov.
For information about participating at all sites, contact AstraZeneca Clinical Study Information Center by email or phone: 1-877-240-9479.
Andrew Tutt, MB ChB PhD
Guy's Hospital, Great Maze Pond, London