Status:
COMPLETED
Docetaxel, Vinorelbine and Trastuzumab in the Treatment of Patients With Metastatic Her-2 Positive Breast Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Aventis Pharmaceuticals
GlaxoSmithKline
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In this phase II trial we attempt to improve upon the efficacy of the trastuzumab/vinorelbine combination by adding weekly docetaxel. When administered on a weekly schedule, docetaxel is well tolerate...
Detailed Description
Upon determination of eligibility, all patients will be receive: Trastuzumab + Vinorelbine + Docetaxel
Eligibility Criteria
Inclusion
- To be included in this study, you must meet the following criteria:
- Metastatic breast cancer confirmed by biopsy
- Overexpression of the Her-2 oncogene
- Age \> 18 years
- Measurable disease
- Able to perform activities of daily living with minimal assistance
- No previous chemotherapy for metastatic disease
- One or more previous hormonal therapies for metastatic disease.
- Adequate bone marrow, liver and kidney function
- Patients with \< grade 1 peripheral neuropathy are eligible.
- Must give written informed consent prior to entering this study.
Exclusion
- You cannot participate in this study if any of the following apply to you:
- Abnormal heart function
- Previous treatment with trastuzumab
- Brain metastases untreated
- Pre-existing symptomatic peripheral neuropathy
- 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.
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00193089
Start Date
April 1 2001
End Date
September 1 2009
Last Update
December 10 2015
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