A Study Evaluating Safety and Efficacy of the Addition of ABT-888 Plus Carboplatin Versus the Addition of Carboplatin to Standard Chemotherapy Versus Standard Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Triple Negative Breast Cancer

In brief

This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage TNBC.

Key facts

Study ID

NCT02032277

Run by

AbbVie

People needed

634

Starts

2014-04-02

Expected to finish

2020-11-12

Last updated by the study team

2021-01-20

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed invasive breast cancer by core needle or incisional biopsy (excisional biopsy is not allowed). Clinical stage T2-3 N0-2 or T1 N1-2 by physical exam or radiologic studies.
• Documented Breast Cancer Gene (BRCA) germline mutation testing.
• Estrogen Receptor (ER)-, Progesterone Receptor (PR)-, and Human Epidermal Growth Factor Receptor (HER)2-negative (triple-negative) cancer of the breast.
• ECOG Performance status of 0 to 1.
• Women must be determined to be not of childbearing potential (surgically sterile, or postmenopausal defined as amenorrheic for at least 12 months) by the Investigator OR they must have a negative serum pregnancy test prior to randomization.

You may not qualify if…

• Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy radiotherapy or investigational agents) with therapeutic intent for current breast cancer.
• Previous treatment with carboplatin, paclitaxel, doxorubicin, cyclophosphamide and a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.
• Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (SERM). Subjects must have discontinued use of such agents prior to beginning study treatment.
• A history of seizure within 12 months prior to study entry.
• Pre-existing neuropathy from any cause in excess of Grade 1.

Where it is running

• Mayo Clinic - Scottsdale /ID# 139932 — Scottsdale, Arizona, United States
• Arizona Oncology Associates, PC-HOPE /ID# 126137 — Tucson, Arizona, United States
• Usc /Id# 123310 — Los Angeles, California, United States
• Pacific Cancer Care /ID# 120476 — Salinas, California, United States
• Sharp Memorial Hospital /ID# 119861 — San Diego, California, United States
• Stanford University School of Med /ID# 130316 — Stanford, California, United States
• Cedars-Sinai Medical Center - West Hollywood /ID# 137275 — West Hollywood, California, United States
• Christiana Care Health Service /ID# 137823 — Newark, Delaware, United States
• Florida Cancer Specialists - Fort Myers /ID# 121835 — Fort Myers, Florida, United States
• Florida Cancer Specialists - Fort Myers /ID# 126379 — Fort Myers, Florida, United States
• Mayo Clinic /ID# 132349 — Jacksonville, Florida, United States
• Mount Sinai Comp Cancer Ctr /ID# 133008 — Miami, Florida, United States
• Miami Cancer Institute - Baptist Health South Florida /ID# 126145 — Miami, Florida, United States
• UF Health Cancer Center /ID# 141589 — Orlando, Florida, United States
• Moffitt Cancer Center /ID# 124063 — Tampa, Florida, United States
• University of Illinois - Chicago /ID# 134329 — Chicago, Illinois, United States
• Northwestern University Feinberg School of Medicine /ID# 133848 — Chicago, Illinois, United States
• University of Chicago DCAM /ID# 120467 — Chicago, Illinois, United States
• Loyola University Medical Ctr /ID# 120455 — Maywood, Illinois, United States
• OSF St. Anthony Medical Center /ID# 139424 — Rockford, Illinois, United States
• Indiana Univ School Medicine /ID# 118215 — Indianapolis, Indiana, United States
• Community Rgnal Cancer Care N /ID# 120456 — Indianapolis, Indiana, United States
• Horizon Oncology Research Center /ID# 116815 — Lafayette, Indiana, United States
• Cancer Center of Kansas /ID# 134720 — Wichita, Kansas, United States
• Scottsdale Healthcare /ID# 120473 — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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