Table 2.
OlympiAd and EMBRACA trial characteristics.
| Study Name | Design (R ratio) | Population, N | Treatment armsa | Endpoints |
|---|---|---|---|---|
| OlympiAd | RCT (2:1) | HER2-negative BC, 302 - TN, 150 - HR+, 152 ≤2 prior CT lines for MBC (prior treatment with anthracycline and taxane for EBC or MBC; prior platinum salts permitted if DFI ≥12 months or no evidence of PDb) ≤1 prior ET lines for MBC in HR + BC |
Olaparib (tablets, 300 mg twice daily) Chemotherapy: - Capecitabine (tablets, 2500 mg/mq for 14 days on-7days off) - Eribulin-mesylate (1.4 mg/mq iv dd1-8, q3w) - Vinorelbine (30 mg/mq iv dd1-8, q3w) | Primary: PFS by blinded central review (according to RECIST 1.1) Secondary: OS; ORR; safety outcomes (adverse events were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events – CTCAE – v 4.0); QoL (30-item European Organization for Research and Treatment of Cancer Quality of Life Questionnaire -QLQ-C30). |
| EMBRACA | RCT (2:1) | HER2-negative BC, 431 - TN, 190 - HR+, 241 ≤3 prior CT lines for MBC (prior treatment with anthracycline and/or taxane for EBC or MBC; prior platinum salts permitted if DFI ≥6 months or no evidence of PDb) no limit on the number of prior ET lines in HR + BC | Talazoparib (tablets, 1 mg once daily) Chemotherapyc: - Capecitabine (oral, 1250 mg/m2, twice daily, for 14 days on-7days off) - Eribulin-mesylate (1.4 mg/mq iv dd1-8, q3w) - Vinorelbine (30 mg/m2, weekly iv dd1-8-15 q3w) - Gemcitabine (1250 mg/m2, ivdd1-8 q3w) | Primary: PFS by blinded central review (according to RECIST 1.1) Secondary: OS; ORR; CBR; safety (according to CTCA v 4.0), patient-reported outcomes (QLQ-C30 and breast cancer-specific QLQ-BR23) |
List of abbreviationsR, randomization; RCT, randomized clinical trial; BC, breast cancer; EBC, early breast cancer; MBC, metastatic breast cancer; TN, triple-negative; HR+, hormone receptor-positive; CT, chemotherapy; ET, endocrine therapy; PD, progressive disease; mq, square meters; iv, intravenous; dd, days; q3w, every 3 weeks; PFS, progression-free survival; OS, overall survival; ORR, objective response rate; CBR, clinical benefit rate; QoL, quality of life
Cross-over was not permitted in neither OlympiAd nor Embraca.
In the OlympiAd trial, 29.3% of patients in the olaparib arm and 26.8% in the control arm had already received platinum-based therapy. In the EMBRACA trial, 16.0% of patients in the talazoparib arm and 20.8% in the control arms had already received platinum therapy.
Suggested dosing schedules were noted, but if institution dose and regimen guidelines differed, the site may utilize institution guidelines.