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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193076
• Other study ID #: SCRI BRE 63
• Secondary ID: B9E-US-S324H3036
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: May 2, 2011
• Start date: November 2003
• Est. completion date: October 2008

Study information

• Verified date: May 2011
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Gemcitabine + Carboplatin

Other known NCT identifiers

• NCT00191776

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: October 2008
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Gemcitabine
Gemcitabine
• Carboplatin
Carboplatin
• Trastuzumab
Trastuzumab

Locations

Country	Name	City	State
United States	Tennessee Oncology	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Eli Lilly and Company, Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 B — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rates		18 Months	No