Weekly Gemcitabine and Trastuzumab in the Treatment of Patients With HER2 Positive Metastatic Breast Cancer

This study has been completed.

First Received: September 12, 2005 Last Updated: January 15, 2009 History of Changes

Sponsors and Collaborators:	Sarah Cannon Research Institute Eli Lilly and Company Genentech
Information provided by:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00193063

Purpose

Due to its remarkable activity as salvage treatment in women with metastatic breast cancer as well as the additive activity observed for gemcitabine administered in combination with trastuzumab, the clinical activity of the combination of gemcitabine administered with trastuzumab represents an exciting and ideal combination to further evaluate in Her 2 over-expressing metastatic breast cancer patients.

Condition	Intervention	Phase
Breast Cancer	Drug: Trastuzumab Drug: Gemcitabine	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Trial of Weekly Gemcitabine and Herceptin in the Treatment of Patients With HER-2 Overexpressing Metastatic Breast Cancer

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:

assess the feasibility and toxicity of the combination of weekly gemcitabine and trastuzumab in the treatment of metastatic breast cancer overexpressing Her-2.

Secondary Outcome Measures:

efficacy of this combination regimen in the treatment of metastatic breast cancer patients.

Estimated Enrollment:	60
Study Start Date:	July 2001

Detailed Description:

Upon determination of eligibility, all patients will be receive:

Gemcitabine + Trastuzumab

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

Her-2 positive metastatic breast cancer confirmed by biopsy
Measurable disease
Able to perform activities of daily living without considerable
No previous chemotherapy with gemcitabine
No more than one prior chemotherapy regimen for metastatic breast cancer
Adequate bone marrow, liver and renal function
Normal heart function
Give written informed consent prior to entering this study.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

Received previous treatment with gemcitabine
History of brain metastases
Serious underlying medical conditions

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193063

Sponsors and Collaborators

Sarah Cannon Research Institute

Eli Lilly and Company

Genentech

Investigators

Principal Investigator:

Denise A. Yardley, MD

Sarah Cannon Research Institute

More Information

No publications provided

Responsible Party:	Sarah Cannon Research Institute ( Denise A. Yardley, M.D. )
Study ID Numbers:	SCRI BRE 44, B9E-MC-X339, H2371n
Study First Received:	September 12, 2005
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00193063 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Radiation-Sensitizing Agents
Immunologic Factors
Skin Diseases
Trastuzumab

Breast Neoplasms
Gemcitabine
Immunosuppressive Agents
Antiviral Agents
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Breast Neoplasms
Enzyme Inhibitors

Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Trastuzumab
Gemcitabine
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009