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Research & Clinical Trials > Study Search Tool > Cisplatin With or Without Veliparib in Treating Patients With Stage IV Triple-Negative and/or BRCA Mutation-Associated Breast Cancer

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Cisplatin With or Without Veliparib in Treating Patients With Stage IV Triple-Negative and/or BRCA Mutation-Associated Breast Cancer

This study is open to:

Patients with metastatic (stage IV) triple negative or BRCA-mutation associated breast cancer including those with stable or progressive brain metastasis.

Breast Cancer Brain Metastasis Cohort

  • Patients with stable brain metastasis, can participate in the main study and those with progressive brain metastasis can participate in the brain metastasis cohort. 
  • Patients with progressive disease have previously had brain radiation therapy (either focused or whole brain radiation), and are now experiencing progression (growth) of their brain metastases. 
This study is not open to:

Patients with Her2-positive breast cancer are excluded. 

Cisplatin With or Without Veliparib in Treating Patients With Stage IV Triple-Negative and/or BRCA Mutation-Associated Breast Cancer

Cisplatin With/Without Veliparib for Metastatic BRCA or TNBC

Clinicaltrials.gov identifier:
NCT02595905

Treatment:
Breast

Study Contact Information

The study is open in over 500 locations throughout the US, with sites in most states and Puerto Rico. All sites can be viewed here on clinicaltrials.gov. For more information about the study contact Southwest Oncology Group

About the Study

This study is for with people with advanced breast cancer and a BRCA mutation or triple-negative breast cancer. This study is open to people with spread of the cancer to their brain or other places in their body. The study will compare whether adding the PARP inhibitor veliparib to the chemotherapy cisplatin improves response over chemotherapy alone. Veliparib is a PARP inhibitor that inhibits the ability of cancer cell to fix DNA damage caused by chemotherapy.  This drug combination could be important for patients who have brain metastasis because veliparib and cisplatin both cross the blood brain barrier. The goal of this study is to treat metastatic breast cancer within the brain and outside of the brain (i.e. in other parts of the body) at the same time. 

This study is important because most studies for people with metastatic breast cancer exclude patients who have spread to the brain. This study is open to people with brain metastasis

For more information, visit the study listing on clinicaltrials.gov.

Type of Study

Randomized, Double-blinded, 2-arm Placebo-controlled Study

  • The study has two arms. This means that patients in the study are placed in one of two different groups. 
  • This study is placebo-controlled. One group will received the treatment cisplatin plus the PARP inhibitor veliparib and the other group will receive cisplatin plus a placebo.
  • 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 is double-blinded. This means that participants will be randomly selected to one of two groups. Neither the participants nor their doctors will know whether they are receiving veliparib or the placebo while participating in the study.  

What the Study Entails

  • Participants will be randomized to one of two groups. Both groups will be on 21-day cycles; receiving Cisplatin on day 1 of the 21 day cycle.  
    • One group will also take the PARP inhibitor, veliparib orally on days 1-14 of a 21-day cycle.  
    • One group will take a placebo orally on days 1-14 of the 21-day cycle. 

Study Lead Investigator

Eve Rodler, MD Southwest Oncology Group (SWOG)

Study Sites

The study is open in over 500 locations throughout the US, with sites in most states and Puerto Rico. All sites can be viewed here on clinicaltrials.gov. For more information about the study contact Southwest Oncology Group

Sites include: AR (1 site), AK (8 sites), CA (49 sites), CO (43 sites), CT (3 sites) DE (9 sites) FL (5 sites), GA (4 sites), ID (13 sites) IL (46 sites), IN (8 sites), IA (22 sites), KS (20 sites), KY (13 sites), LA (7 sites), ME (2 sites), MD (1 site), MI (81 sites), MN (29 sites), MS (3 sites), MO (25 sites), MT (9 sites), NE (10 sites), NH (3 sites), NJ (3 sites), NM (5 sites), NY (3 sites), NC (13 sites), ND (6 sites), OH (69 sites), OK (6 sites), OR (13 sites), PA (36 sites), SC (14 sites), SD (2 sites), TN (6 sites), TX (6 sites), UT (3 sites), VT (1 site), VA (1 site), WA (38 sites), WV (2 sites), WI (40 sites), WY (3 sites), Puerto Rico (11 sites)

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