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

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
Genentech
Information provided by:
Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:
NCT00193076
First received: September 12, 2005
Last updated: May 2, 2011
Last verified: May 2011
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
 Drug: Gemcitabine
Drug: Carboplatin
Drug: Trastuzumab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:
  • Overall response rates [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: November 2003
Study Completion Date: October 2008
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Gemcitabine
    Gemcitabine
    Drug: Carboplatin
    Carboplatin
    Drug: Trastuzumab
    Trastuzumab
Detailed Description:

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

Gemcitabine + Carboplatin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193076

Locations
United States, Tennessee
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Sarah Cannon Research Institute
Eli Lilly and Company
Genentech
Investigators
Principal Investigator: Denise A. Yardley, MD Sarah Cannon Research Institute
  More Information

Additional Information:
Published article in Clinical Breast Cancer  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Denise A. Yardley, M.D., Sarah Cannon Research Institute
ClinicalTrials.gov Identifier: NCT00193076     History of Changes
Obsolete Identifiers: NCT00191776
Other Study ID Numbers: SCRI BRE 63, B9E-US-S324, H3036S
Study First Received: September 12, 2005
Last Updated: May 2, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Trastuzumab
Carboplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 23, 2013