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Cisplatin With or Without Veliparib in Treating Patients With Recurrent or Metastatic Triple-Negative and/or BRCA Mutation-Associated Breast Cancer With or Without Brain Metastases
Sponsor: National Cancer Institute (NCI)
Summary
This randomized phase II trial studies how well cisplatin works with or without veliparib in treating patients with triple-negative breast cancer and/or BRCA mutation-associated breast cancer that has come back (recurrent) or has or has not spread to the brain (brain metastases). Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as veliparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. It is not yet known if cisplatin is more effective with or without veliparib in treating patients with triple-negative and/or BRCA mutation-associated breast cancer.
Official title: Phase II Randomized Placebo-Controlled Trial of Cisplatin With or Without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer and/or BRCA Mutation-Associated Breast Cancer, With or Without Brain Metastases
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
344
Start Date
2016-09-15
Completion Date
2025-03-21
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
Cisplatin
Given IV
Laboratory Biomarker Analysis
Correlative studies
Placebo Administration
Given PO
Veliparib
Given PO
Locations (810)
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States
Anchorage Radiation Therapy Center
Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States
Alaska Women's Cancer Care
Anchorage, Alaska, United States
Anchorage Oncology Centre
Anchorage, Alaska, United States
Katmai Oncology Group
Anchorage, Alaska, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States
Kaiser Permanente-Anaheim
Anaheim, California, United States
Sutter Auburn Faith Hospital
Auburn, California, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, United States
Kaiser Permanente-Baldwin Park
Baldwin Park, California, United States
Kaiser Permanente-Bellflower
Bellflower, California, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
Mills-Peninsula Medical Center
Burlingame, California, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States
Mercy San Juan Medical Center
Carmichael, California, United States
Eden Hospital Medical Center
Castro Valley, California, United States
Sutter Davis Hospital
Davis, California, United States
Epic Care-Dublin
Dublin, California, United States
Mercy Cancer Center - Elk Grove
Elk Grove, California, United States
Bay Area Breast Surgeons Inc
Emeryville, California, United States
Epic Care Partners in Cancer Care
Emeryville, California, United States
Kaiser Permanente-Fontana
Fontana, California, United States
Palo Alto Medical Foundation-Fremont
Fremont, California, United States
Kaiser Permanente South Bay
Harbor City, California, United States
Kaiser Permanente-Irvine
Irvine, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Kaiser Permanente West Los Angeles
Los Angeles, California, United States
Contra Costa Regional Medical Center
Martinez, California, United States
Fremont - Rideout Cancer Center
Marysville, California, United States
Mercy Cancer Center
Merced, California, United States
Memorial Medical Center
Modesto, California, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States
Sutter Cancer Research Consortium
Novato, California, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States
Bay Area Tumor Institute
Oakland, California, United States
Kaiser Permanente-Ontario
Ontario, California, United States
Saint Joseph Hospital - Orange
Orange, California, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States
Kaiser Permanente - Panorama City
Panorama City, California, United States
Eisenhower Medical Center
Rancho Mirage, California, United States
Kaiser Permanente-Riverside
Riverside, California, United States
Mercy Cancer Center - Rocklin
Rocklin, California, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States
Sutter Roseville Medical Center
Roseville, California, United States
Mercy Cancer Center - Sacramento
Sacramento, California, United States
Sutter Medical Center Sacramento
Sacramento, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Kaiser Permanente-San Diego Mission
San Diego, California, United States
Kaiser Permanente-San Diego Zion
San Diego, California, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States
Kaiser Permanente-San Marcos
San Marcos, California, United States
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, United States
Epic Care Cyberknife Center
Walnut Creek, California, United States
Woodland Memorial Hospital
Woodland, California, United States
Kaiser Permanente-Woodland Hills
Woodland Hills, California, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States
The Medical Center of Aurora
Aurora, Colorado, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
Boulder Community Hospital
Boulder, Colorado, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, United States
Memorial Hospital North
Colorado Springs, Colorado, United States
Denver Health Medical Center
Denver, Colorado, United States
National Jewish Health-Main Campus
Denver, Colorado, United States
The Women's Imaging Center
Denver, Colorado, United States
AdventHealth Porter
Denver, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, United States
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
Mercy Medical Center
Durango, Colorado, United States
Southwest Oncology PC
Durango, Colorado, United States
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Mountain Blue Cancer Care Center
Golden, Colorado, United States
National Jewish Health-Western Hematology Oncology
Golden, Colorado, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States
Grand Valley Oncology
Grand Junction, Colorado, United States
Banner North Colorado Medical Center
Greeley, Colorado, United States
Rocky Mountain Cancer Centers-Greenwood Village
Greenwood Village, Colorado, United States
Good Samaritan Hospital - Cancer Centers of Colorado
Lafayette, Colorado, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, United States
Saint Anthony Hospital
Lakewood, Colorado, United States