Status:
COMPLETED
Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer
Lead Sponsor:
Harold J. Burstein, MD, PhD
Collaborating Sponsors:
Dana-Farber Cancer Institute
Genentech, Inc.
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the effectiveness and safety of administering Herceptin in combination with Taxol (paclitaxel) in the treatment of women with HER2-positive, early stage breas...
Detailed Description
Patients will receive Herceptin intravenously once weekly for 12 weeks, and Taxol intravenously every 3 weeks (week 1, week 4, week 7 and week 10). After 12 weeks of treatment, breast surgery will be...
Eligibility Criteria
Inclusion
- Patients must have Stage II or III histologically diagnosed breast cancer
- Primary invasive breast cancers that overexpress the HER2/neu oncogene
- Age older than 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of \< 1
- White blood cell (WBC) \> 4000/mm3
- Platelet count \> 100,000/mm3
- Bilirubin \< 1 x upper limit of normal (ULN)
- SGOT \< 1 x ULN
- Creatinine \< 1.5mg/dl
- Normal cardiac function and electrocardiogram (EKG) showing absence of ischemic changes or ventricular hypertrophy
Exclusion
- Excisional biopsy, sentinel node dissection or axillary node dissection.
- Prior history of breast cancer unless: diagnosed at least 2 years ago, present cancer is not in a previously irradiated breast, no prior therapy with anthracycline or taxane, no prior high-dose chemotherapy with stem cell or bone marrow transplant.
- Pregnant or breast-feeding women
- Uncontrolled infection
- Active or severe cardiovascular or pulmonary disease
- Peripheral neuropathy of any etiology that exceeds grade 1
- Prior history of malignancy treated without curative intent
- Uncontrolled diabetes
Key Trial Info
Start Date :
March 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00136539
Start Date
March 1 1999
End Date
March 1 2012
Last Update
February 18 2013
Active Locations (2)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115