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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

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


Upon determination of eligibility, all patients will be receive:

Trastuzumab + Vinorelbine + Docetaxel


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

18 Months

Safety Issue:

No

Principal Investigator

John D. Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Institutional Review Board

Study ID:

SCRI BRE 46

NCT ID:

NCT00193089

Start Date:

April 2001

Completion Date:

September 2009

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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