Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in HER-2 Positive Breast Cancer

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find out what effects the preoperative combination therapies of herceptin/navelbine or herceptin/taxotere/carboplatin will have on patients with early stage HER-2 positive breast cancer.

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

Details

• Lead Sponsor: Eric Winer, MD
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Dana-Farber Cancer Institute; Massachusetts General Hospital; Yale University
• Treatments: Carboplatin; Docetaxel; Trastuzumab; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• Patients with stage II or III breast cancer

• HER-2 positive tumors

• Older than 18 years of age

• Eastern Cooperative Oncology Group (ECOG) Performance Status of greater or equal to 1.

• ANC > 1,500/mm3

• Hemoglobin > 9gm/dl

• Platelets > 100,000mm3

• Creatinine < 2mg/dl

• Glucose < 200mg/dl

• Bilirubin < 1.5 x ULN

Exclusion Criteria:

• Previous treatment with herceptin, taxanes, doxorubicin or other anthracycline-type therapy, navelbine, or platinum-based therapy.

• Pregnant or breast-feeding women

• Serious illness, or medical or psychiatric condition

• Uncontrolled infections

• Active or severe cardiovascular or pulmonary disease

• Patients with left ventricular ejection fraction < 50%

• Peripheral neuropathy of any etiology that exceeds grade 1

• Prior history of malignancy

• Uncontrolled diabetes