Study With Docetaxel, Carboplatin and Herceptin Versus Vinorelbine and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients

Sponsor
Hellenic Oncology Research Group
Study ID
NCT00453635
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Docetaxel — DRUG
    Docetaxel at the dose of 75mg/m\^2 IV on day 1 every 3 weeks for 6 consecutive cycles
  • Carboplatin — DRUG
    Carboplatin at the dose of 5 AUC IV on day 1 every 3 weeks for 6 consecutive cycles
  • Herceptin — DRUG
    Herceptin 8 mg/Kg on day 1 for the first cycle and 6 mg/Kg for the 5 remaining cycles, IV, every 3 weeks
  • Vinorelbine — DRUG
    Vinorelbine at the dose of 60mg/m\^2 per os,weekly

Study Details

This trial will compare the efficacy of sequential administration of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination as first line treatment in HER-2 positive patients with metastatic breast cancer.

Key Dates

Start date
Dec 31, 2003
Status verified
Mar 2012
Primary completion
Nov 30, 2008
Completion
Nov 30, 2008

Study Design

Enrollment
88 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Docetaxel + Carboplatin + Herceptin (D/Carbo/Her)
  • Experimental: 2
    Vinorelbine + Herceptin (VHer)

Primary Outcome Measure

Time to progression between the two treatment arms [ Time Frame: 1 year ]

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