drugset / Trial / NCT04224922
Phase II Study of Neoadjuvant Weekly Paclitaxel and Carboplatin Followed by Dose Dense Epirubicin and Cyclophosphamide in Stage II and III Triple Negative Breast Cancer
Phase 2
Completed
63 enrolled
University Hospital Brussels
Universitaire Ziekenhuizen KU Leuven · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a prospective Belgian, multi-center, open-label, single-arm phase II study of weekly paclitaxel at a dose of 80mg/m² in combination with weekly carboplatin (AUC=2), for 12 weeks, followed by 4 cycles of dose dense epirubicin at a dose of 90 mg/m² and cyclophosphamide at a dose of 600 mg/m² every 2 weeks (plus Long acting GCSF at day 2) administrated preoperatively in locally advanced operable stage II and III triple negative breast cancer to evaluate tumor response in the breast and the axilla.
Timeline
- Start
- 2015-05
- Primary completion
- 2016-07
- Completion
- 2017-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | — |
| Subject | Cyclophosphamide | Other / unclassified | 600 mg/m2 | — |
| Subject | Epirubicin | Small molecule | 90 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | — |