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

Sponsor
Danish Breast Cancer Cooperative Group
Study ID
NCT00430001
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • docetaxel — DRUG
  • vinorelbine — DRUG
  • trastuzumab — DRUG

Study Details

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.

Key Dates

Start date
May 31, 2005
Status verified
May 2008
Completion
Dec 31, 2008

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Primary Outcome Measure

Disease free survival [ Time Frame: median ]

Central Contacts

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