Stage IV Breast Cancer Clinical Trial
Official title:
Phase I Study of ABT-888 in Combination With Cisplatin and Vinorelbine for Patients With Advanced Triple Negative Breast Cancer and/or BRCA-Mutation Associated Breast Cancer
This phase I trial studies the side effects and best dose of veliparib when given together with cisplatin and vinorelbine ditartrate in treating patients with breast cancer that has returned or spread to other parts of the body. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and vinorelbine ditartrate, 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. Giving veliparib together with combination chemotherapy may be a better treatment for breast cancer.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of ABT-888 (veliparib) when administered
daily for 14 days out of a 21 day cycle in combination with cisplatin and vinorelbine
(vinorelbine ditartrate) in subjects with metastatic triple negative breast cancer (TNBC) and
breast cancer (BRCA) mutation associated breast cancer.
SECONDARY OBJECTIVES:
I. Assess the pharmacokinetic profile of ABT-888 when combined with cisplatin and vinorelbine
and the safety/tolerability profile of the combination.
II. Evaluate the level of poly ADP ribose polymerase (PARP) inhibition at each dose level to
determine whether maximal PARP inhibition is achieved.
III. Identify the subgroup of triple negative breast cancer patients who will potentially
derive the most benefits from PARP inhibition combined with platinum-based chemotherapy.
OUTLINE: This is a dose-escalation study of veliparib.
Patients receive veliparib orally (PO) twice daily (BID) on days 1-14 (days 0-13 of course 1
only). Patients also receive cisplatin intravenously (IV) over 1 hour on day 1 and
vinorelbine ditartrate IV over 10-20 minutes on days 1 and 8. Treatment repeats every 21 days
for 6-10 courses in the absence of disease progression or unacceptable toxicity. Treatment
with veliparib alone may continue in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed for up to 30 days.
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