drugset / Trial / NCT01484080
Neoadjuvant Paclitaxel Versus BIBF 1120 Priming Followed by BIBF 1120 Plus Paclitaxel in Early HER-2 Negative Breast Cancer With Proteomic and Dynamic Imaging Correlates
Phase 1/2
Completed
140 enrolled
Spanish National Cancer Research Centre
Grupo Espanol de Investigacion del Cancer de Mama · collabHospital Universitari de Bellvitge · collabHospital Universitario de Fuenlabrada · collabM.D. Anderson Cancer Center · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The investigators plan to study the efficacy of the combination of weekly paclitaxel + BIBF 1120 in early breast cancer using a neoadjuvant schedule and a randomized phase-II trial design, comparing the efficacy vs. weekly paclitaxel alone, followed by surgery and subsequent standards of care (anthracycline based chemotherapy, radiation or hormonal blockade).
Timeline
- Start
- 2011-10
- Primary completion
- 2013-11
- Completion
- 2014-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nintedanib | Small molecule | — | Oral |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |