Neoadjuvant Chemotherapy + Herceptin in HER2 Positive Stage II-III Breast Cancer Patients

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

Summary

The purpose of this study is to evaluate the effectiveness and tolerability of the combination of the following medications given every two weeks in HER2 positive breast cancer patients:

• trastuzumab (Herceptin)

• epirubicin (Ellence)

• cyclophosphamide (Cytoxan)

• docetaxel (Taxotere)

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

Details

• Lead Sponsor: Accelerated Community Oncology Research Network
• Collaborator: Aventis Pharmaceuticals
• Treatments: Cyclophosphamide; Docetaxel; Epirubicin; Trastuzumab

Criteria

Inclusion Criteria:

• Non-pregnant females =/> 18 years of age

• Non-inflammatory breast cancer stage IIA - IIIC or high risk node negative

• Core biopsy of breast demonstrating invasive cancer and documented ER/PgR receptor status

• Normal cardiac function and adequate hematologic function

• Human epidermal growth factor receptor 2 protein (HER2) positive

• No evidence of metastatic disease

• ECOG Performance Status 0 - 1

• Women of childbearing potential must agree to using effective contraception while on treatment and for at least 3 months post-treatment

Exclusion Criteria:

• Treated with other investigational drugs within 30 days

• Uncontrolled intercurrent disease or active infection

• Known sensitivity to e. coli-derived proteins or polysorbate 80

• Psychiatric illness or social situation that would limit study compliance

• Pre-existing peripheral neuropathy > Grade 1

• Cancer within 5 years of screening with the exception of surgically cured nonmelanomatous skin cancer; in-situ carcinoma of the cervix; or in-situ carcinoma of the breast

• Bilateral synchronous breast cancer

• Inflammatory breast cancer

• Women who are pregnant or breast feeding