Status:
UNKNOWN
Vinorelbine Plus (+) Trastuzumab vs Docetaxel Plus (+) Trastuzumab as 1 Line Treatment for HER2 Positive (+) Metastatic Breast Cancer
Lead Sponsor:
Danish Breast Cancer Cooperative Group
Collaborating Sponsors:
Hoffmann-La Roche
Sanofi
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-74 years
Phase:
PHASE3
Brief 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 rece...
Eligibility Criteria
Inclusion
- Locally advanced or metastatic HER2-positive breast cancer
- WHO performance status \< 3
Exclusion
- Chemotherapy for metastatic breast cancer or adjuvant therapy within 12 months with docetaxel, vinorelbine or trastuzumab
- Severe dyspnoea
- Abnormal organ function including cardiac
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00430001
Start Date
May 1 2005
End Date
December 1 2008
Last Update
May 9 2008
Active Locations (1)
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1
Department of Oncology, Rigshospitalet
Copenhagen, Denmark, 2100