Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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 breast cancer prior to surgery.

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

Details

• Lead Sponsor: Harold J. Burstein, MD, PhD
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Bristol-Myers Squibb; Dana-Farber Cancer Institute; Genentech, Inc.; Harvard Vanguard Medical Associates; Massachusetts General Hospital
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Paclitaxel; Trastuzumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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