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Vinorelbine Plus (+) Trastuzumab vs Docetaxel Plus (+) Trastuzumab as 1 Line Treatment for HER2 Positive (+) Metastatic Breast Cancer

Phase 3
Conditions
Breast Cancer
Registration Number
NCT00430001
Lead Sponsor
Danish Breast Cancer Cooperative Group
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 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
300
Inclusion Criteria
  • Locally advanced or metastatic HER2-positive breast cancer
  • WHO performance status < 3
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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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Primary Outcome Measures
NameTimeMethod
Disease free survivalmedian
Secondary Outcome Measures
NameTimeMethod
response rate, overall survival, toxicityMedian

Trial Locations

Locations (1)

Department of Oncology, Rigshospitalet

🇩🇰

Copenhagen, Denmark

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