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A Phase II Trial of Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

A Phase II Trial of Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer

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

Gemcitabine + Carboplatin

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rates

Outcome Time Frame:

18 Months

Safety Issue:


Principal Investigator

Denise A. Yardley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

November 2003

Completion Date:

October 2008

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



Tennessee Oncology Nashville, Tennessee  37203