drugset / Trial / NCT01242449
Oral Vinorelbine in Combination With Trastuzumab for Metastatic Breast Cancer
Non-randomizedFactorialOpen-labelTreatment
Summary
This phase II study will investigate oral vinorelbine 90 mg/m2 on days 1 + 8 at 3 weeks intervals in combination with trastuzumab as 1st and 2nd line treatment of women with metastatic HER2 positive breast cancer. Oral vinorelbine has shown the same overall response rate as i.v. vinorelbine in metastatic breast cancer, and capsules are generally better tolerated.
Timeline
- Start
- 2010-11
- Primary completion
- 2012-10
- Completion
- 2014-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Vinorelbine | Small molecule | 90 mg/m2 | Oral |