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Weekly Gemcitabine and Trastuzumab in the Treatment of Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00193063
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : March 12, 2014
Last Update Posted : March 12, 2014
Sponsor:
Collaborators:
Eli Lilly and Company
Genentech, Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: Trastuzumab Drug: Gemcitabine Phase 2

Detailed Description:

Upon determination of eligibility, all patients will be receive:

Gemcitabine + Trastuzumab

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Weekly Gemcitabine and Herceptin in the Treatment of Patients With HER-2 Overexpressing Metastatic Breast Cancer
Study Start Date : July 2001
Actual Primary Completion Date : May 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
 Drug: Trastuzumab
Trastuzumab
Other Name: Herceptin

Drug: Gemcitabine
Gemcitabine
Other Name: Gemzar


Outcome Measures
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Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: 18 Months ]
    The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 21 Months ]
    The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  2. Overall Survival (OS) [ Time Frame: 24 months ]
    The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193063


Sponsors and Collaborators
SCRI Development Innovations, LLC
Eli Lilly and Company
Genentech, Inc.
Investigators
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Principal Investigator: Denise A. Yardley, MD SCRI Development Innovations, LLC
More Information
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Additional Information:

Publications of Results:

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Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00193063    
Other Study ID Numbers: SCRI BRE 44
First Posted: September 19, 2005    Key Record Dates
Results First Posted: March 12, 2014
Last Update Posted: March 12, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Trastuzumab
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological