Three arm randomized parallel phase II/III study evaluating the efficacy and safety of the combinations Epirubicin and Taxotere (ET), Taxotere and Navelbine (TN) and Navelbine and Epirubicin (EN) as first line therapy in pat. with metastatic breast cancer.
Completed
- Conditions
- Metastic breast cancer.
- Registration Number
- NL-OMON29407
- Lead Sponsor
- VU medical center.
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 111
Inclusion Criteria
1. Histologically proven breast cancer at first diagnosis. At study entry histological or cytological proof of metastasis is required in case of a single metastatic target lesion.
Female metastatic breast cancer patients
Measurable disease or evaluable disease (bone metastases only allowed).
Exclusion Criteria
1. Prior chemotherapy for metastatic disease.
2. Locally advanced inoperable breast cancer (Stage III B) as only manifestation of the disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to progression, response rate.
- Secondary Outcome Measures
Name Time Method Toxicity profile, feasibility.