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veliparib plus paclitaxel plus carboplatin (n=316) vs. Standard of Care (SoC) (n=160)
randomized controlled trial
veliparib plus paclitaxel plus carboplatin
veliparib: 50mg PO twice a day (self-administered monring and evening) / paclitaxel: 80mg/m² IV weekly for 12 doses / carboplatin: AUC 6mg/mL per min IV every 3 weeks for four cycles
placebo plus paclitaxel plus carboplatin
placebo matching veliparib: 50mg PO twice a day (self-administered morning and evening) / paclitaxel: 80mg/m² IV weekly for 12 doses / carboplatin: AUC 6mg/mL per min IV every 3 weeks for four cycles
all groups received segment 2 treatment xith doxorubicin (60mg/m²) ans cyclophosphamide (600mg/m²) every 2 or 3 weeks for four cycles to complete neoadjuvant regimen.
mBC - TNBC - L1 - all population
Patients were ineligible if they had received previous anti-cancer treatment
double-blind
145 sites in 15 countries (Australia, Europe, Korea, Taiwan, USA)
P3 / Fixed-sequence testing procedure used to control the Type I error rate at 0.05 (2-sided) : 1a) pCR: arm A vs arm C > 1b) pCR: A vs B (1a and 1b must be both significant to continue) > 2) EFS: Arm A vs C > 3) EFS: Arm A vs B > OS: Arm A vs C > 4) OS: Arm A vs B > 5) BCR: A vs C > 6) BCR: A vs B / 2 unblided safety review by IDMC during trial
the proportion of patients who achived a pathological complet response was not different between the 2 groups
veliparib plus paclitaxel plus carboplatin (n=316) vs. Standard of Care (SoC) (n=158)
randomized controlled trial
veliparib plus paclitaxel plus carboplatin
veliparib: 50mg PO twice a day (self-administered monring and evening) / paclitaxel: 80mg/m² IV weekly for 12 doses / carboplatin: AUC 6mg/mL per min IV every 3 weeks for four cycles
placebo matching veliparib plus placebo matching carboplatin plus paclitaxel
placebo matching veliparib: 50mg PO twice a day (self-administered monring and evening) / paclitaxel: 80mg/m² IV weekly for 12 doses / placebo matching carboplatin: 0.9% sodium chloride injection every 3 weeks for four cycles
all groups received segment 2 treatment xith doxorubicin (60mg/m²) ans cyclophosphamide (600mg/m²) every 2 or 3 weeks for four cycles to complete neoadjuvant regimen.
mBC - TNBC - L1 - all population
Patients were ineligible if they had received previous anti-cancer treatment
double-blind
145 sites in 15 countries (Australia, Europe, Korea, Taiwan, USA)
P3 / Fixed-sequence testing procedure used to control the Type I error rate at 0.05 (2-sided) : pCR arm A vs arm C > pCR A vs B > BCR(Breast Conservation Rate) A vs C > RCB (Residual Cancer Burden) A vs C > BCR A vs B > RCB A vs B / 2 unblided safety review by IDMC during trial
the proportion of patients who achieved a pathological complete response was significantly higher in the study group than in the comparator group
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