Preoperative Herceptin and Navelbine for Breast Cancer
Completed · Phase 2
Conditions studied: Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT00148681
- Run by
- Dana-Farber Cancer Institute
- People needed
- 49
- Starts
- 2001-05-01
- Expected to finish
- 2003-05-01
- Last updated by the study team
- 2019-01-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Dana-Farber Cancer Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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