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OpenTrials
Completed

NCT Number: NCT00193063

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

Upon determination of eligibility, all patients will be receive:

Gemcitabine + Trastuzumab

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trastuzumab

Drug

Trastuzumab

Other names: Herceptin

Gemcitabine

Drug

Gemcitabine

Other names: Gemzar

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Eli Lilly and Company
  • Genentech, Inc.

Registry information

Official study title

Phase II Trial of Weekly Gemcitabine and Herceptin in the Treatment of Patients With HER-2 Overexpressing Metastatic Breast Cancer

Important dates

Study start
2001
Primary completion
2009
Study completion
2009
First posted
Sep 19, 2005
Registry last updated
Mar 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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