Status:
COMPLETED
IRS Proteins and Trastuzumab Resistance
Lead Sponsor:
University of Massachusetts, Worcester
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Brief Summary
Significant progress has been made in the treatment of women with Her2 positive breast cancer who are treated with trastuzumab, a humanized monoclonal antibody that inhibits Her2. Despite this progres...
Detailed Description
Twenty percent of invasive breast cancers overexpress Her2 neu. These breast cancers are more aggressive with a higher relapse rate and shortened overall survival. Trastuzumab is a humanized monoclona...
Eligibility Criteria
Inclusion
- Women age 18-70 with breast cancer who have signed an IRB approved consent form.
- Biopsy proven breast cancer with her 2 overexpression by fluorescence in situ hybridization (FISH).
- Newly diagnosed patients with Stages 1,2 and 3 breast cancer who will be receiving neoadjuvant chemotherapy prior to breast surgery
- Normal Left ventricular ejection fraction, as measured by echocardiogram or MUGA scan
- Normal bone marrow, kidney and liver function
- No evidence of distant metastatic disease
Exclusion
- Patients with significant cardiac disease including abnormal LVEF, symptomatic coronary artery disease, uncontrolled hypertension.
- Prior treatment with chemotherapy.
- Any cancer other than previously treated skin cancer.
- Breast cancer in a previously irradiated breast.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00657345
Start Date
March 1 2008
End Date
February 1 2013
Last Update
November 5 2013
Active Locations (1)
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1
University of Mass Medical School
Worcester, Massachusetts, United States, 01655