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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00193076
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : May 3, 2011
Eli Lilly and Company
Genentech, Inc.
Information provided by:
SCRI Development Innovations, LLC

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Gemcitabine Drug: Carboplatin Drug: Trastuzumab Phase 2

Detailed Description:

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

Gemcitabine + Carboplatin

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer
Study Start Date : November 2003
Actual Primary Completion Date : May 2006
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Intervention Details:
    Drug: Gemcitabine
    Drug: Carboplatin
    Drug: Trastuzumab

Primary Outcome Measures :
  1. Overall response rates [ Time Frame: 18 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00193076

United States, Tennessee
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
SCRI Development Innovations, LLC
Eli Lilly and Company
Genentech, Inc.
Principal Investigator: Denise A. Yardley, MD SCRI Development Innovations, LLC

Additional Information:
Publications of Results:
Responsible Party: Denise A. Yardley, M.D., Sarah Cannon Research Institute Identifier: NCT00193076     History of Changes
Obsolete Identifiers: NCT00191776
Other Study ID Numbers: SCRI BRE 63
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: May 3, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs