drugset / Trial / NCT02810743
Substantially Improving the Cure Rate of High-risk BRCA1-like Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
Investigator-initiated, international, multicentre, randomized, open-label, (neo)adjuvant phase III study in target population (stage III, HER2-negative, BRCA1-like breast cancer patients) comparing optimized standard-dose chemotherapy with intensified, alkylating chemotherapy with stem cell rescue.
Timeline
- Start
- 2017-01-25
- Primary completion
- 2024-07-18
- Completion
- 2033-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Comparator | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Comparator | Carboplatin | Small molecule | 400 mg/m2 | Intravenous |
| Comparator | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Comparator | Cyclophosphamide | Other / unclassified | 3000 mg/m2 | Intravenous |
| Comparator | Olaparib | Small molecule | 300 mg | Oral |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Comparator | Thiotepa | Other / unclassified | 250 mg/m2 | — |
| Comparator | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | 500 mg | — |
| Comparator | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | 2000 mg | — |
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | — |
| Comparator | Capecitabine | Small molecule | 1250 mg/m2 | — |
| Comparator | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Comparator | Pegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |