Weekly Gemcitabine and Trastuzumab in the Treatment of Patients With HER2 Positive Metastatic Breast Cancer
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- assess the feasibility and toxicity of the combination of weekly gemcitabine and trastuzumab in the treatment of metastatic breast cancer overexpressing Her-2. [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
- efficacy of this combination regimen in the treatment of metastatic breast cancer patients. [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2001 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
-
Drug: Trastuzumab
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 |
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 More Information
Additional Information:
Publications:
| Responsible Party: | Denise A. Yardley, M.D., Sarah Cannon Research Institute |
| ClinicalTrials.gov Identifier: | NCT00193063 History of Changes |
| Other Study ID Numbers: | SCRI BRE 44, B9E-MC-X339, H2371n |
| Study First Received: | September 12, 2005 |
| Last Updated: | May 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Gemcitabine Trastuzumab Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on June 18, 2013