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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

September 12, 2005
May 2, 2011
November 2003
May 2006   (final data collection date for primary outcome measure)
Overall response rates [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
Overall response rates
Complete list of historical versions of study NCT00193076 on ClinicalTrials.gov Archive Site
Not Provided
  • Time to disease progression
  • Overall survival
  • Toxicity of the therapy
Not Provided
Not Provided
 
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

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.

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

Gemcitabine + Carboplatin
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Gemcitabine
    Gemcitabine
  • Drug: Carboplatin
    Carboplatin
  • Drug: Trastuzumab
    Trastuzumab
Not Provided
Yardley DA, Burris Iii HA, Simons L, Spigel DR, Greco FA, Barton JH, Shipley D, Drosick D, Hainsworth JD. A Phase II Trial of Gemcitabine/Carboplatin with or Without Trastuzumab in the First-Line Treatment of Patients with Metastatic Breast Cancer. Clin Breast Cancer. 2008 Oct;8(5):425-31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
October 2008
May 2006   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00193076
SCRI BRE 63, B9E-US-S324, H3036S
Not Provided
Denise A. Yardley, M.D., Sarah Cannon Research Institute
Sarah Cannon Research Institute
  • Eli Lilly and Company
  • Genentech
Principal Investigator: Denise A. Yardley, MD Sarah Cannon Research Institute
Sarah Cannon Research Institute
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP