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Phase II Trial of Weekly Gemcitabine and Herceptin in the Treatment of Patients With HER-2 Overexpressing Metastatic Breast Cancer


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

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Trial Information

Phase II Trial of Weekly Gemcitabine and Herceptin in the Treatment of Patients With HER-2 Overexpressing Metastatic Breast Cancer


Upon determination of eligibility, all patients will be receive:

Gemcitabine + Trastuzumab


Inclusion Criteria:



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

- Her-2 positive metastatic breast cancer confirmed by biopsy

- Measurable disease

- Able to perform activities of daily living without considerable

- No previous chemotherapy with gemcitabine

- No more than one prior chemotherapy regimen for metastatic breast cancer

- Adequate bone marrow, liver and renal function

- Normal heart function

- 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:

- Received previous treatment with gemcitabine

- History of brain metastases

- 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:

assess the feasibility and toxicity of the combination of weekly gemcitabine and trastuzumab in the treatment of metastatic breast cancer overexpressing Her-2.

Outcome Time Frame:

18 Months

Safety Issue:

No

Principal Investigator

Denise A. Yardley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI BRE 44

NCT ID:

NCT00193063

Start Date:

July 2001

Completion Date:

August 2009

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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