Weekly Gemcitabine and Trastuzumab in the Treatment of Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2009-08-31

Brief Summary

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Due to its remarkable activity as salvage treatment in women with metastatic breast cancer as well as the additive activity observed for gemcitabine administered in combination with trastuzumab, the clinical activity of the combination of gemcitabine administered with trastuzumab represents an exciting and ideal combination to further evaluate in Her 2 over-expressing metastatic breast cancer patients.

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Detailed Description

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Upon determination of eligibility, all patients will be receive:

Gemcitabine + Trastuzumab

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.

Group Type EXPERIMENTAL

Trastuzumab

Intervention Type DRUG

Trastuzumab

Gemcitabine

Intervention Type DRUG

Gemcitabine

Interventions

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Trastuzumab

Intervention Type DRUG

Gemcitabine

Intervention Type DRUG

Other Intervention Names

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Herceptin Gemzar

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No