NCT00193076CompletedPhase 2
A Phase II Trial of Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer
SCRI Development Innovations, LLC2 sites in 1 country96 target enrollmentStarted: November 2003Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 96
- Locations
- 2
- Primary Endpoint
- Overall response rates
Study Overview
Brief Summary
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
Upon determination of eligibility, all patients will receive the following treatment:
Gemcitabine + Carboplatin
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Overall response rates
Time Frame: 18 Months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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