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olaparib (n=921) vs. placebo (n=915)
randomized controlled trial
olaparib
olaparib: 300mg twice a day PO (2 tablets of 150mg at the same time each morning and evening of each day with approximately 240mL of water (12 hours appart))
placebo
placebo: PO 2 tablets at the same time each morning and evening of each day with approximately 240mL of water (12 hours appart))
breast cancer - adjuvant
Exclusion criteria: any previous treatment with a PARP inhibitor
double-blind
in 420 centers across 23 countries
P3 / IDFS at 2-sided 5% (2.5% 1-sided), with 1 IA at 0.005 level. / If IDFS is statistically significant, alpha level will be split for DDFS (4%) and OS (1%), 2 IA dos DDFS and 3 IA for OS. If DDFS is statistically significant, aplha level for DDFS will be recylced to OS and split across the planned analyses (and vice versa if OS is significant, level alpha for OS will be recyled to DDFS) see p-value in protocol.
Results from ESMO virutal plenary
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
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
olaparib (n=205) vs. Standard of Care (SoC) (n=97)
randomized controlled trial
olaparib
olaparib: tablets 300mg twice daily
standard chemotherapy
capecitabine PO 2500 mg per square meter of body-surface area daily (divided into two doses) for 14 days, repeated every 21 days / eribulin mesylate IV 1.4 mg per square meter on day 1 and day 8, repeated every 21 days / or vinorelbine IV 30 mg per square meter on day 1 and day 8, repeated every 21 days.
mBC - TNBC - L2 - all population
Patients with hormone-receptor positive breast cancer had received at least one endocrine therapy.
open-label
169 centers in 18 countries (Asia, Europe, Mexico, Peru, USA)
P3 / PFS, PFS2 (time to 2nd progression) and OS will be tested at a 2-sided significance level of 5% in this order. No interim analysis for the PE (PFS). PFS2 and OS will be split between the initial and final analysis : A 2-sided significance level of 0.025 will be assigned to the initial analysis of PFS2 and OS
this study showed an improvement statistically significant for the PFS with the olaparib, however the OS was not different between groups.
talazoparib (n=287) vs. Standard of Care (SoC) (n=144)
randomized controlled trial
talazoparib
talazoparib: 1mg PO once daily continuously
chemotherapy
protocol-specified single-agent chemotherapy (capecitabine, eribulin, gemcitabine, orvinorelbine) in coutinuous 21-day cycle
mBC-Triple negative (TNBC) - 2nd Line (L2)
open-label
145 sites in 16 countries
P3 / PFS at 2-sided with a 0.05 level of significance. ORR then OS were tested after, hirearchically at a level of 0.05, if PFS was significant. Control of the type I error rate by employing a fixed-sequence testing procedure at 0.05 / An interim analysis for OS at the time of the unblinding PFS (if PFS and ORR are significant)
the overall survival was not significantly improved in the talazoprib group compared to chemotherapy group
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