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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2008-10-31

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.

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Detailed Description

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Upon determination of eligibility, all patients will receive the following treatment:

Gemcitabine + Carboplatin

Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Gemcitabine

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Trastuzumab

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No