Status:
COMPLETED
Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Eli Lilly and Company
Genentech, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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...
Detailed Description
Upon determination of eligibility, all patients will receive the following treatment: Gemcitabine + Carboplatin
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2008
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00193076
Start Date
November 1 2003
End Date
October 1 2008
Last Update
May 3 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tennessee Oncology
Nashville, Tennessee, United States, 37203