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

NCT00453635 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2012-03-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Docetaxel

Docetaxel at the dose of 75mg/m\^2 IV on day 1 every 3 weeks for 6 consecutive cycles

DRUG

Carboplatin

Carboplatin at the dose of 5 AUC IV on day 1 every 3 weeks for 6 consecutive cycles

DRUG

Herceptin

Herceptin 8 mg/Kg on day 1 for the first cycle and 6 mg/Kg for the 5 remaining cycles, IV, every 3 weeks

DRUG

Vinorelbine

Vinorelbine at the dose of 60mg/m\^2 per os,weekly

Sponsors & Collaborators

  • University Hospital of Crete

    collaborator OTHER

  • Hellenic Oncology Research Group

    lead OTHER

Principal Investigators

  • Dimitris Mavroudis, MD · University Hospital of Crete, Dep of Medical Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • Greece

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00453635 on ClinicalTrials.gov