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

This study has been completed.
Eli Lilly and Company
Genentech, Inc.
Information provided by:
SCRI Development Innovations, LLC Identifier:
First received: September 12, 2005
Last updated: May 2, 2011
Last verified: May 2011
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:

Further study details as provided by SCRI Development Innovations, LLC:

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
    Drug: Carboplatin
    Drug: Trastuzumab
Detailed Description:

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

Gemcitabine + Carboplatin


Ages Eligible for Study:   18 Years and older
Genders 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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  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
Breast Diseases
Neoplasms by Site
Skin Diseases
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses processed this record on May 04, 2016