Veliparib With or Without Carboplatin in Treating Patients With Stage IV Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01149083|
Recruitment Status : Active, not recruiting
First Posted : June 23, 2010
Last Update Posted : March 17, 2021
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Breast Carcinoma Metastatic Breast Carcinoma Stage III Breast Cancer AJCC v7 Stage IIIA Breast Cancer AJCC v7 Stage IIIB Breast Cancer AJCC v7 Stage IIIC Breast Cancer AJCC v7 Stage IV Breast Cancer AJCC v6 and v7 Unresectable Breast Carcinoma||Drug: Carboplatin Other: Laboratory Biomarker Analysis Drug: Veliparib||Phase 2|
I. To evaluate the efficacy of single agent veliparib (ABT-888) (NSC 737664) in breast cancer (BRCA) carriers with metastatic breast cancer based on response rate (Response Evaluation Criteria In Solid Tumors [RECIST] criteria).
I. To conduct subset analysis on BRCA1 versus (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 adenosine diphosphate (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 s a dose-escalation study of veliparib. 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.
After completion of study treatment, patients are followed up every 3-6 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 30, 2010|
|Estimated Primary Completion Date :||December 31, 2021|
Experimental: Arm I (veliparib)
Patients receive veliparib PO BID on days 1-21.
Other: Laboratory Biomarker Analysis
Experimental: Arm II (veliparib, carboplatin)
Patients receive carboplatin IV over 30 minutes on day 1 and veliparib as in Arm I.
Other: Laboratory Biomarker Analysis
- Response rate [ Time Frame: Up to 4 years ]Measured by Response Evaluation Criteria in Solid Tumors version 1.1.
- Progression-free survival [ Time Frame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 4 years ]Compared between arms using the log-rank test. Analyzed using Kaplan-Meier plots and multivariate Cox regression.
- Toxicity [ Time Frame: Up to 4 years ]Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 and 5.0. Assessed and summarized with descriptive statistics.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01149083
|Principal Investigator:||Joanne Mortimer||City of Hope Comprehensive Cancer Center|