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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2005

Detailed Description

Upon determination of eligibility, all patients will be receive: Trastuzumab + Vinorelbine + Docetaxel

Interventions

  • Drug: Docetaxel
    • Docetaxel
  • Drug: Vinorelbine
    • Vinorelbine
  • Drug: Trastuzumab
    • Trastuzumab

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • SCRI Development Innovations, LLC
  • Collaborator
    • Aventis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • John D. Hainsworth, MD, Principal Investigator, SCRI Development Innovations, LLC

Citations Reporting on Results

Infante JR, Yardley DA, Burris HA 3rd, Greco FA, Farley CP, Webb C, Spigel DR, Hainsworth JD. Phase II trial of weekly docetaxel, vinorelbine, and trastuzumab in the first-line treatment of patients with HER2-positive metastatic breast cancer. Clin Breast Cancer. 2009 Feb;9(1):23-8. doi: 10.3816/CBC.2009.n.004.

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