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Research & Clinical Trials > Study Search Tool > A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer (BROCADE3)

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A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer (BROCADE3)

This study is open to:
  • Patients with metastatic breast cancer or locally advanced breast cancer for which local therapy (surgery or radiation) is not appropriate. 
  • Patients must have a BRCA1 or BRCA2 mutation.
  • Patients must be Her2-negative.

 

This study is not open to:

Patients may not be pregnant or breastfeeding.

A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer (BROCADE3)

BROCADE3 - Veliparib in Metastatic BRCA-Associated Breast Cancer

Clinicaltrials.gov identifier:
NCT02163694

Treatment:
Breast

Study Contact Information

The study is open in 240 locations globally, including sites in many states. For information regarding BROCADE3, contact Abbvie Emerging Med at: (844) 893-5525 or by email.

 

About the Study

The Brocade 3 Study is a research study evaluating an investigational drug for men and women with metastatic or locally advanced breast cancer that is BRCA-associated.

Type of Study:

Randomized, Double-blinded, 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 PARP inhibitor veliparib plus the treatments carboplatin and paclitaxel and the other group will receive a placebo plus the treatments carboplatin and paclitaxel. 
  • 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. This randomizing is a 2:1 randomized study. This means that patients will have a slightly greater chance of being placed in the veliparib plus treatment group than the placebo plus treatment group. 
  • 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 plus treatment or the placebo plus treatment 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 Carboplatin and Taxol on day 1 of the 21 day trial.  
    • One group will also receive the PARP inhibitor, veliparib on days 2-5 of a 21-day cycle.  
    • One group will receive a placebo on days 2-5 of the 21-day cycle. 

Study Sites

The study is open in 240 locations globally, including sites in many states. For information regarding BROCADE3, contact Abbvie Emerging Med at: (844) 893-5525 or by email.

Sites in the United States include: AZ, AK, CA, CT, CO, FL, GA, IL, IA, MD, MA, MI, MS, MO, NE, NJ, NM, NY, NC, OH, OR, PA, TX, VT, WI

International sites include: Argentina, Australia, Austria, Belarus, Belgium, Canada, Chile, Colombia, Czech Republic, Denmark, Eastonia, Finland, France, Germany, Hungary, Israel, Italy, Korea, Latvia, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Singaport, South Africa, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom

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