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Vinorelbine Plus (+) Trastuzumab vs Docetaxel Plus (+) Trastuzumab as 1 Line Treatment for HER2 Positive (+) Metastatic Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Metastatic breast neoplasm
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: docetaxel
Type: Drug
Name: vinorelbine
Type: Drug
Name: trastuzumab
Type: Drug
Overall Status
Recruiting
Summary
In an open-label randomised phase III-trial patients with metastatic HER2-positive breast cancer naive to chemotherapy with normal organ function and WHO performance status < 3 are randomised to receive either docetaxel 100 mg/m2 i.v. plus trastuzumab 6 mg/kg (8 mg/kg loading dose) q 3 weeks or vinorelbine 30 or 35 mg/m2 days 1+8 plus trastuzumab 6 mg/kg (8 mg/kg loading dose) q 3 weeks. Primary endpoint is time to progression. Secondary endpoints include overall survival, time to treatment failure, response rate, duration of response and toxicity. The study hypothesis is that docetaxel is more efficient than vinorelbine but also more toxic.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 74 Years
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:
- Locally advanced or metastatic HER2-positive breast cancer
- WHO performance status < 3
Exclusion Criteria:
- Chemotherapy for metastatic breast cancer or adjuvant therapy within 12 months with docetaxel, vinorelbine or trastuzumab
- Severe dyspnoea
- Abnormal organ function including cardiac
- Locally advanced or metastatic HER2-positive breast cancer
- WHO performance status < 3
Exclusion Criteria:
- Chemotherapy for metastatic breast cancer or adjuvant therapy within 12 months with docetaxel, vinorelbine or trastuzumab
- Severe dyspnoea
- Abnormal organ function including cardiac
Location
Department of Oncology, Rigshospitalet
Copenhagen, Denmark
Status: Recruiting
Start Date
May 2005
Completion Date
December 2008
Sponsors
Danish Breast Cancer Cooperative Group
Source
Danish Breast Cancer Cooperative Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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