Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03330847 | To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy. | PHASE2 | ACTIVE NOT_RECRUITING | 273 | — | — | Mar 7, 2018 | Sep 4, 2026 | Mar 10, 2026 | 141 | United States, Belgium +13 |
Progression-free survival was defined as time from randomization until the date of objective disease progression or death, regardless of whether the patient withdrew from randomized therapy or received another anti-cancer therapy prior to progression. Progression was determined by Blinded independent central review (BICR) using Response Evaluation Criteria In Solid Tumours Version (RECIST 1.1). Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST assessment. If patients had no evaluable visits or baseline data, the patient was censored at Study Day 1, unless death occurred within 17 weeks i.e., death within 17 weeks was relative to randomization. Here, the study patient population was stratified as follows: Breast cancer susceptible gene mutation (BRCAm) patients; non BRCAm homologous recombination repair gene mutation (HRRm) patients; non HRRm patients.
Progression-free survival was defined as time from randomization until the date of objective disease progression or death, regardless of whether the patient withdrew from randomized therapy or received another anti-cancer therapy prior to progression. Progression was determined by the site Investigator. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment. If patients had no evaluable visits or baseline data, the patient was censored at Study Day 1, unless death occurred within 17 weeks i.e., death within 17 weeks was relative to randomization. Here, the study patient population was stratified as follows: BRCAm patients; non BRCAm HRRm patients; non HRRm patients.
| Arm | Type | Description |
|---|---|---|
| Olaparib monotherapy | ACTIVE_COMPARATOR | All randomized patients will receive Olaparib monotherapy 300 mg twice daily (BD). |
| Olaparib+Ceralasertib | ACTIVE_COMPARATOR | All randomized patients will receive Olaparib 300 mg twice daily+Ceralasertib 160 mg once daily (OD). |
| Olaparib+adavosertib | ACTIVE_COMPARATOR | All randomized patients will receive Olaparib 200 mg BD +adavosertib 150 mg BD. Following the discontinuation of adavosertib+olaparib treatment arm on 18 April 2019, patients receiving treatment with adavosertib+olaparib treatment were offered the opportunity to continue treatment on olaparib monotherapy at the approved dose (300 mg bd). |
| Name | Type | Description |
|---|---|---|
| Olaparib Continuous (28-Day cycle) 300 mg BD. | DRUG | Two (2) 150 mg olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water (approximately 250 mL). |
| Ceralasertib 160 mg OD + olaparib continuous 300 mg BD (28-day cycle). | DRUG | Patients will be administered Ceralasertib OD at 160 mg from Day 1 to Day 7 (inclusive) of every 28-day cycle. |
| Adavosertib 150 mg BD + olaparib 200 mg BD (21-day cycle). | DRUG | Patients will be administered adavosertib BD at 150mg from Day 1 to Day 3 and Day 8 to Day 10. |
Pertinent Inclusion criteria: 1. Informed consent prior to any study specific procedures. 2. Male or female ≥18 years of age. 3. Progressive cancer at the time of study entry. 4. Histologically or cytologically confirmed TNBC at initial diagnosis with evidence of metastatic disease and HER2 negativ...