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Completed

NCT Number: NCT00193089

Docetaxel, Vinorelbine and Trastuzumab in the Treatment of Patients With Metastatic Her-2 Positive Breast Cancer

In this phase II trial we attempt to improve upon the efficacy of the trastuzumab/vinorelbine combination by adding weekly docetaxel. When administered on a weekly schedule, docetaxel is well tolerated with minimal myelosuppression, so that it is likely that fully efficacious doses of all three drugs can be administered

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

Upon determination of eligibility, all patients will be receive:

Trastuzumab + Vinorelbine + Docetaxel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

To be included in this study, you must meet the following criteria:

  • Metastatic breast cancer confirmed by biopsy
  • Overexpression of the Her-2 oncogene
  • Age > 18 years
  • Measurable disease
  • Able to perform activities of daily living with minimal assistance
  • No previous chemotherapy for metastatic disease
  • One or more previous hormonal therapies for metastatic disease.
  • Adequate bone marrow, liver and kidney function
  • Patients with < grade 1 peripheral neuropathy are eligible.
  • Must give written informed consent prior to entering this study.

Exclusion criteria

You cannot participate in this study if any of the following apply to you:

  • Abnormal heart function
  • Previous treatment with trastuzumab
  • Brain metastases untreated
  • Pre-existing symptomatic peripheral neuropathy
  • Serious underlying medical conditions

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Treatment and study plan

docetaxel

Drug

Docetaxel

Vinorelbine

Drug

Vinorelbine

Trastuzumab

Drug

Trastuzumab

Primary outcomes

  1. feasibility and toxicity of the combination of weekly docetaxel, vinorelbine, and trastuzumab in patients with metastatic breast cancer who overexpress Her-2.

    Time frame: 18 Months

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Aventis Pharmaceuticals
  • GlaxoSmithKline

Registry information

Official study title

Phase II Trial of Weekly Docetaxel, Vinorelbine, and Herceptin in the First-Line Treatment of Patients With Metastatic Breast Cancer and Overexpression of Her-2

Important dates

Study start
2001
Primary completion
2005
Study completion
2009
First posted
Sep 19, 2005
Registry last updated
Dec 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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