Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer

Study Overview
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Brief Summary
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Pre-clinical data suggests that combination therapy with gemcitabine and carboplatin is synergistic, and both drugs may be synergistic with trastuzumab. Additionally, recent clinical data suggest that the combination of gemcitabine with platinum is an active regimen in metastatic breast cancer. This study will test the combination of gemcitabine with carboplatin in patients with metastatic breast cancer. Patients with Her2/neu overexpression will be stratified to receive trastuzumab in addition to gemcitabine and carboplatin.

Detailed Description
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Upon determination of eligibility, all patients will receive the following treatment: Gemcitabine + Carboplatin

Official Title
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A Phase II Trial of Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Gemcitabine
* Drug: Carboplatin
* Drug: Trastuzumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be included in this study, you must meet the following criteria: Locally advanced or metastatic breast cancer Measurable disease as per RECIST criteria No prior chemotherapy in the metastatic breast setting Prior chemotherapy and/or hormonal therapy for early stage breast cancer Adjuvant Herceptin is allowed Prior radiation therapy in either the metastatic or early stage setting Patients may have received any number of hormonal therapies Age >18 years Only women are eligible for the study Able to perform activities of daily living with minimal assistance Normal organ and bone marrow function Patients who will be receiving Trastuzumab must have normal heart function Sign a written informed consent document Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Received prior chemotherapy for metastatic breast cancer Known leptomeningeal carcinomatosis Uncontrolled brain metastasis Uncontrolled intercurrent illness Pregnant or lactating History of other non-breast cancer malignancy Received prior chemotherapy for early stage breast cancer within 6 months 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gemcitabine|Gemcitabine|
|Drug: Carboplatin|Carboplatin|
|Drug: Trastuzumab|Trastuzumab|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rates |  | 18 Months |