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

Completed · Phase 2

Conditions studied: Breast Neoplasm

In brief

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)

Key facts

Study ID

NCT00270894

Run by

Accelerated Community Oncology Research Network

People needed

30

Starts

2005-11-01

Expected to finish

2011-08-01

Last updated by the study team

2012-03-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Advanced Medical Specialties — Miami, Florida, United States
• Augusta Oncology Associates — Augusta, Georgia, United States
• Cental Georgia Cancer Care — Macon, Georgia, United States
• Northwest Georgia Oncology Centers, PC — Marietta, Georgia, United States
• Hematology Oncology Centers of the Northern Rockies, PC — Billings, Montana, United States
• Arena Oncology Associates — Great Neck, New York, United States
• The West Clinic — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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