Status:
COMPLETED
Preoperative Herceptin and Navelbine for Breast Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Conditions:
Breast Cancer
Stage II Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to find out what effects the preoperative combination therapy of herceptin and navelbine have on HER-2 positive breast cancer.
Detailed Description
* As part of the patients pre-treatment evaluation, a clip will be placed within the tumor bed so that the surgeon can find it at the time of surgery. Four biopsies of the tumor will be obtained at th...
Eligibility Criteria
Inclusion
- EGOG performance status of 0-1
- HER2 overexpressing (IHC 3+ or FISH +)
- Stage II or III breast cancer. Clinical T1N1M) and inflammatory (T4) breast cancer are eligible
- Patients with metastatic breast cancer (Stage IV) which is limited to supraclavicular and/or infraclavicular node positivity are eligible
- 18 years of age or older
Exclusion
- Prior therapy with herceptin, paclitaxel or other taxane, doxorubicin or other anthracycline-type chemotherapy, navelbine
- Pregnant or lactating women
- Uncontrolled infections, including AIDS
- History or symptoms diagnostic of systemic connective tissue or inflammatory disease
- Active or severe cardiovascular or pulmonary disease, including recent myocardial infarction or deep-venous thrombosis/pulmonary embolism, congestive heart failure, uncontrolled hypertension, or steroid-dependent asthma.
- Left ventricular ejection fraction \< 50%
- Peripheral neuropathy of any etiology that exceeds grade 1
- Prior history of malignancy treated without curative intent
- Uncontrolled diabetes
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2003
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00148681
Start Date
May 1 2001
End Date
May 1 2003
Last Update
January 15 2019
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
3
Dana-Farber Cancer Center
Boston, Massachusetts, United States, 02215