- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00193076
Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer
A Phase II Trial of Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Upon determination of eligibility, all patients will receive the following treatment:
Gemcitabine + Carboplatin
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37203
- Tennessee Oncology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall response rates
Time Frame: 18 Months
|
18 Months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Denise A. Yardley, MD, SCRI Development Innovations, LLC
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Gemcitabine
- Carboplatin
- Trastuzumab
Other Study ID Numbers
- SCRI BRE 63
- B9E-US-S324
- H3036S
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Trastuzumab
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-
Spanish Breast Cancer Research GroupCompleted
-
Fudan UniversityHoffmann-La RocheUnknown
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingHER2-positive Breast Cancer | Early-stage Breast Cancer | Adjuvant Treatment After Trastuzumab | RCB Classification 1-2 | NeratiniChina
-
Orano Med LLCCompletedStomach Neoplasms | Breast Neoplasms | Pancreatic Neoplasms | Ovarian Neoplasms | Peritoneal NeoplasmsUnited States
-
National Cancer Institute (NCI)Active, not recruitingMale Breast Carcinoma | Stage IIA Breast Cancer AJCC v6 and v7 | Stage IIB Breast Cancer AJCC v6 and v7 | Stage IIIA Breast Cancer AJCC v7 | Stage IIIB Breast Cancer AJCC v7 | Stage IIIC Breast Cancer AJCC v7United States, Puerto Rico
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Fudan UniversityCompleted