drugset / Trial / NCT02299999
SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
Open label multicentric phase II randomized trial, using high throughput genome analysis as a therapeutic decision tool, which aims at comparing a targeted treatment administered according to the identified molecular anomalies of the tumor with maintenance chemotherapy (targeted substudy 1) as well as immunotherapy with maintenance chemotherapy in patients without actionable genomic alterations or non eligible to substudy 1 (immune substudy 2).
Timeline
- Start
- 2014-04-07
- Primary completion
- 2022-12
- Completion
- 2025-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bicalutamide | Other / unclassified | 150 mg | Oral |
| Subject | Capivasertib | Small molecule | 480 mg | Oral |
| Subject | Durvalumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Fexagratinib | Small molecule | 80 mg | Oral |
| Subject | Olaparib | Small molecule | 300 mg | Oral |
| Subject | SAPITINIB | Small molecule | 40 mg | Oral |
| Subject | Selumetinib | Small molecule | 75 mg | Oral |
| Subject | Vandetanib | Small molecule | 300 mg | Oral |
| Subject | Vistusertib | Small molecule | 50 mg | Oral |
| Comparator | Bevacizumab | Monoclonal antibody | — | — |
| Comparator | Capecitabine | Small molecule | — | — |
| Comparator | Carboplatin | Small molecule | — | — |
| Comparator | Cisplatin | Other / unclassified | — | — |
| Comparator | Cyclophosphamide | Other / unclassified | — | — |
| Comparator | Docetaxel | Small molecule | — | — |
| Comparator | Doxorubicin | Other / unclassified | — | — |
| Comparator | Epirubicin | Small molecule | — | — |
| Comparator | Eribulin | Small molecule | — | — |
| Comparator | Gemcitabine | Small molecule | — | — |
| Comparator | Methotrexate | Small molecule | — | — |
| Comparator | Mitomycin C | Other / unclassified | — | — |
| Comparator | Paclitaxel | Small molecule | — | — |
| Comparator | Vinblastine | Small molecule | — | — |
| Comparator | Vincristine | Small molecule | — | — |
| Comparator | Vinorelbine | Small molecule | — | — |
| Comparator | fluorouracil | Small molecule | — | — |