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

SCRI Development Innovations

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Gemcitabine; Drug: Trastuzumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00193063

SCRI BRE 44

Details and patient eligibility

About

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.

Full description

Upon determination of eligibility, all patients will be receive:

Gemcitabine + Trastuzumab

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Intervention

Experimental group

Description:

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.

Treatment:

Drug: Trastuzumab

Drug: Gemcitabine