Veliparib With or Without Carboplatin in Treating Patients With Stage III or Stage IV Breast Cancer
This phase II trial is studying giving veliparib together with carboplatin to see how well they work compared to veliparib alone in treating patients with stage III or stage IV breast cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether veliparib is more effective with or without carboplatin in treating breast cancer.
BRCA1 Mutation Carrier
BRCA2 Mutation Carrier
Recurrent Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Single Agent ABT-888 With Post-Progression Therapy of ABT-888 in Combination With Carboplatin in Patients With Stage IV BRCA-Associated Breast Cancer|
- Response rate as measured by RECIST version 1.1 [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 4 years ] [ Designated as safety issue: No ]Compared between arms using the log-rank test. Analyzed using Kaplan-Meier plots and multivariate Cox regression.
- Toxicity graded according to the NCI CTCAE version 4.0 [ Time Frame: Up to 4 years ] [ Designated as safety issue: Yes ]Assessed and summarized with descriptive statistics.
|Study Start Date:||June 2010|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Arm I (veliparib)
Patients receive veliparib PO BID on days 1-21.
Other Name: ABT-888
Experimental: Arm II (veliparib, carboplatin)
Patients receive carboplatin IV over 30 minutes on day 1 and veliparib as in arm I.
Other Name: ABT-888Drug: carboplatin
I. To evaluate the efficacy of single agent ABT-888 (veliparib) (NSC 737664) in BRCA carriers with metastatic breast cancer based on response rate (Response Evaluation Criteria In Solid Tumors [RECIST] criteria).
I. To conduct subset analysis on breast cancer (BRCA)1 vs. BRCA2 and hormone receptor status.
II. To evaluate progression-free survival of patients on single-agent ABT-888. III. To further describe the safety and tolerability of ABT-888 (NSC 737664) as a single agent and in combination with carboplatin for BRCA-associated breast cancer.
IV. To evaluate the pharmacokinetics of ABT-888 (NSC 737664) alone and in combination with carboplatin.
V. To assess the relationship between the level of poly ADP ribose polymerase (PARP) inhibition by ABT-888 and biomarkers of deoxyribonucleic acid (DNA) damage in peripheral blood mononuclear cell (PBMC's) and in tumor VI. To explore the relationship between biomarkers of drug effect and progression-free survival.
VII. To evaluate the efficacy and safety of the combination of carboplatin and ABT-888 in patients who have failed single agent ABT-888.
VIII. To conduct subset analysis on BRCA1 vs. BRCA2 and hormone receptor status.
OUTLINE: This is a multicenter study. Patients are stratified according to Eastern Cooperative Oncology Group (ECOG) performance status (0-1 vs 2), and hormone status (estrogen receptor [ER]- and/or progesterone receptor [PR]-positive vs ER- and/or PR-negative). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive veliparib orally (PO) twice daily (BID) on days 1-21.
ARM II: Patients receive carboplatin intravenously (IV) over 30 minutes on day 1 and veliparib as in arm I.
In both arms, treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood and hair follicle sample collection for pharmacokinetics and other laboratory studies.
After completion of study therapy, patients are followed up every 3-6 months.
|United States, California|
|City of Hope||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Jeffrey N. Weitzel 800-826-4673|
|Principal Investigator: Jeffrey N. Weitzel|
|University of Southern California||Recruiting|
|Los Angeles, California, United States, 90033-0804|
|Contact: Agustin A. Garcia 323-865-3900 email@example.com|
|Principal Investigator: Agustin A. Garcia|
|UC Davis Comprehensive Cancer Center||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: David R. Gandara 916-734-3771 firstname.lastname@example.org|
|Sub-Investigator: David R. Gandara|
|United States, Colorado|
|University of Colorado||Recruiting|
|Denver, Colorado, United States, 80217-3364|
|Contact: Virginia F. Borges 303-724-0186 email@example.com|
|Principal Investigator: Virginia F. Borges|
|United States, Florida|
|Mayo Clinic in Florida||Recruiting|
|Jacksonville, Florida, United States, 32224-9980|
|Contact: Edith A. Perez 904-953-7283 firstname.lastname@example.org|
|Principal Investigator: Edith A. Perez|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Everett E. Vokes 773-702-9306 email@example.com|
|Principal Investigator: Everett E. Vokes|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21231|
|Contact: Antonio C. Wolff 410-614-4192 firstname.lastname@example.org|
|Principal Investigator: Antonio C. Wolff|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Nadine M. Tung 617-667-7082 email@example.com|
|Principal Investigator: Nadine M. Tung|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Judy E. Garber 617-632-2282 firstname.lastname@example.org|
|Principal Investigator: Judy E. Garber|
|Massachusetts General Hospital Cancer Center||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Steven J. Isakoff 617-726-4920 email@example.com|
|Principal Investigator: Steven J. Isakoff|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Matthew P. Goetz 507-284-2511 firstname.lastname@example.org|
|Principal Investigator: Matthew P. Goetz|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Cynthia X. Ma 314-362-9383 email@example.com|
|Principal Investigator: Cynthia X. Ma|
|United States, New York|
|Montefiore Medical Center-Weiler Division||Recruiting|
|Bronx, New York, United States, 10461|
|Contact: Joseph A. Sparano 718-904-2555 firstname.lastname@example.org|
|Principal Investigator: Joseph A. Sparano|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: David P. Kelsen 212-639-8470 email@example.com|
|Principal Investigator: David P. Kelsen|
|NYU Cancer Institute||Recruiting|
|New York, New York, United States, 10016|
|Contact: Franco M. Muggia 212-652-1917 firstname.lastname@example.org|
|Principal Investigator: Franco M. Muggia|
|Weill Medical College of Cornell University||Recruiting|
|New York, New York, United States, 10065|
|Contact: Tessa Cigler 212-821-0736 email@example.com|
|Principal Investigator: Tessa Cigler|
|United States, Pennsylvania|
|Penn State Milton S Hershey Medical Center||Recruiting|
|Hershey, Pennsylvania, United States, 17033-0850|
|Contact: Chandra P. Belani 717-531-1078 firstname.lastname@example.org|
|Principal Investigator: Chandra P. Belani|
|University of Pittsburgh Cancer Institute||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Contact: Adam M. Brufsky 412-641-6500 email@example.com|
|Principal Investigator: Adam M. Brufsky|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Banu Arun 713-792-2817 firstname.lastname@example.org|
|Principal Investigator: Banu Arun|
|University Health Network-Princess Margaret Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Srikala S. Sridhar 416-946-2249 email@example.com|
|Principal Investigator: Srikala S. Sridhar|
|Principal Investigator:||Jeffrey Weitzel||Beckman Research Institute|