IRB #

IRB00011351

Title

A Phase 3 Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without the PARP Inhibitor Veliparib (ABT-888) in HER2-Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer

Principal Investigator

Kathleen Kemmer

Study Purpose

To determine if veliparib (the study drug) in combination with carboplatin and paclitaxel works better than chemotherapy alone in patients with a BRCA1 or BRCA2 mutation and HER2-negative metastatic or locally advanced breast cancer.

Medical Condition(s)

BRCA1- or BRCA2-positive, HER2-negative metastatic or locally advanced breast cancer

Eligibility Criteria

1. Men and women age 18 or older.
2. Diagnosed with breast cancer that is either locally advanced or metastatic.
3. BRCA1 or BRCA2 positive and HER2 negative.
4. May not have received more than 2 prior lines of chemotherapy for metastatic disease.
5. Additional criteria apply.

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Until disease progression or unacceptable side effects

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080

Sponsor

Abbvie, Inc.

Recruitment End

12/31/2030

Compensation Provided

No


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