Preoperative Herceptin and Navelbine for Breast Cancer

• Status: Completed
• Trial end date: 2003-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Massachusetts General Hospital
• Treatments: Cyclophosphamide; Doxorubicin; Paclitaxel; Trastuzumab; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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