Veliparib will be compared to no veliparib in the BRCA mutation-carriers, BRCA mutation-negative BRCAness-like group, and BRCA mutation-negative non-BRCA-like group. A stratified log-rank test will be used to compare PFS between the two arms in an intention to treat (ITT) analysis where stratification is by line of therapy. In the Progressive Brain Metastases Cohort, veliparib will be compared to no veliparib in patients with active brain metastases that are progressive after prior intracranial therapy. A stratified log-rank test will be used to compare PFS between the two arms in an ITT analysis where stratification is by Modified Breast-Graded Prognostic Assessment (GPA) and prior systemic therapies.
3 separate analyses will be performed: comparing veliparib to no veliparib in the BRCA mutation-carriers, BRCA mutation-negative BRCAness-like group, and BRCA mutation-negative non-BRCA-like group. A stratified log-rank test will be used to compare PFS between the two arms in an intention to treat analysis where stratification is line by line.
Veliparib will be compared to no veliparib in the BRCA mutation-carriers, BRCA mutation-negative BRCAness-like group, and BRCA mutation-negative non-BRCA-like group. A stratified log-rank test will be used to compare OS between the two arms in an ITT analysis where stratification is line by line. In the Progressive Brain Metastases Cohort, veliparib will be compared to no veliparib in patients with active brain metastases that are progressive after prior intracranial therapy. A stratified log-rank test will be used to compare OS between the two arms in an ITT analysis where stratification is by Modified Breast-GPA and prior systemic therapies.
Response rate will be analyzed for patients with measurable disease. Patients who achieve complete or partial response will be classified as having a response. The primary analyses will be conducted using these binary responses using Fisher's exact test and logistic regression.
Clinical benefit will be assessed in all patients and will include those with complete or partial response and those with stable disease for 6 months. The primary analyses will be conducted using these binary responses using Fisher's exact test and logistic regression.
Patients who achieve complete or partial response will be classified as having a response. The primary analyses will be conducted using these binary responses using Fisher's exact test and logistic regression.
Patients receive cisplatin IV over 1 hour on day 1 and placebo PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive cisplatin IV over 1 hour on day 1 and veliparib PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.