Spots Global Cancer Trial Database for HERVIN: Trastuzumab and Vinorelbine in Metastatic Breast Cancer
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Trial Identification
Brief Title: HERVIN: Trastuzumab and Vinorelbine in Metastatic Breast Cancer
Official Title: A Single-centre Phase 2 Study of Vinorelbine Plus 3-weekly Trastuzumab in Metastatic Breast Cancer Overexpressing Her-2
Study ID: NCT00401427
Conditions
Study Description
Brief 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Contact Details
Name: Andrea De Matteis, M.D.
Affiliation: NCI Naples, Division of Medical Oncology C
Role: PRINCIPAL_INVESTIGATOR
Name: Francesco Perrone, M.D., Ph.D.
Affiliation: NCI Naples, Clinical Trials Unit
Role: PRINCIPAL_INVESTIGATOR
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