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Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer

Cancer Type
Breast Cancer
Trial Phase
Phase II
18 Years and older, Male and Female
Study Type
Protocol IDs
M12-895 (primary)
Study Sponsor


The primary objective of the study is to assess the progression-free survival (PFS) of oral
veliparib in combination with TMZ or in combination with carboplatin and paclitaxel compared
to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and
locally recurrent or metastatic breast cancer.


  1. Histologically or cytologically confirmed breast cancer that is either locally recurrent or metastatic.
  2. Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent.
  3. Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline mutation.
  4. If Human Epidermal Growth Factor Receptor (HER2) positive, subjects must have received and progressed on at least one prior standard HER2 directed therapy or the subject must be ineligible to receive anti-HER2 therapy.
  5. Measurable or non-measurable (but radiologically evaluable) disease by RECIST (Response Evaluation Criteria in Solid Tumors) criteria 1.1.
  6. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
  7. Subject must have adequate bone marrow, renal and hepatic function.
  8. Subject must not be pregnant or plan to conceive a child.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE


Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.