Trials / Completed
CompletedNCT00401427
HERVIN: Trastuzumab and Vinorelbine in Metastatic Breast Cancer
A Single-centre Phase 2 Study of Vinorelbine Plus 3-weekly Trastuzumab in Metastatic Breast Cancer Overexpressing Her-2
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (planned)
- Sponsor
- National Cancer Institute, Naples · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The combination of vinorelbine with weekly trastuzumab has produced high response rate in HER2 overexpressing metastatic breast cancer (MBC). The present phase 2 study was planned to test activity of the same combination, with trastuzumab given every 3 weeks, rather than weekly.
Detailed description
The schedule of treatment includes vinorelbine (30 mg/m2 on days 1 \& 8 every 21 days) and trastuzumab (8 mg/kg on day 1 and then 6 mg/kg every 21 days). Vinorelbine is planned for maximum 9 cycles, while trastuzumab can be continued until progression. This study is a single-stage phase 2 design, and patients eligible for response evaluation are required.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | trastuzumab | |
| DRUG | vinorelbine |
Timeline
- Start date
- 2002-11-01
- Primary completion
- 2006-06-01
- Completion
- 2006-12-01
- First posted
- 2006-11-20
- Last updated
- 2012-07-13
Source: ClinicalTrials.gov record NCT00401427. Inclusion in this directory is not an endorsement.