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Trial Title:
Vinorelbine Plus (+) Trastuzumab vs Docetaxel Plus (+) Trastuzumab as 1 Line Treatment for HER2 Positive (+) Metastatic Breast Cancer
NCT ID:
NCT00430001
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Docetaxel
Trastuzumab
Vinorelbine
Conditions: Keywords:
Metastatic breast neoplasm
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Factorial Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
docetaxel
Intervention type:
Drug
Intervention name:
vinorelbine
Intervention type:
Drug
Intervention name:
trastuzumab
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:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
74 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Oncology, Rigshospitalet
Address:
City:
Copenhagen
Zip:
2100
Country:
Denmark
Status:
Recruiting
Start date:
May 2005
Completion date:
December 2008
Lead sponsor:
Agency:
Danish Breast Cancer Cooperative Group
Agency class:
Other
Collaborator:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Collaborator:
Agency:
Sanofi
Agency class:
Industry
Source:
Danish Breast Cancer Cooperative Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00430001
