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

May 2, 2011 updated by: SCRI Development Innovations, LLC

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.

Study Overview

Status

Completed

Conditions

Breast Cancer

Intervention / Treatment

Detailed Description

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

Gemcitabine + Carboplatin

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Tennessee
  - Nashville, Tennessee, United States, 37203
    - Tennessee Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall response rates Time Frame: 18 Months	18 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SCRI Development Innovations, LLC

Collaborators

Eli Lilly and Company

Genentech, Inc.

Investigators

Principal Investigator: Denise A. Yardley, MD, SCRI Development Innovations, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Yardley DA, Burris HA 3rd, 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. doi: 10.3816/CBC.2008.n.051.

Helpful Links

Published article in Clinical Breast Cancer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria