Protocol Title:

A Phase I/II Partial Breast Irradiation with Concurrent Chemotherapy

Protocol Status:

Closed

Protocol Number:

J0381

Type of Cancer:

Breast

Principal Investigator:

Richard Zellars M.D.

Research Nurse:

Shirl DiPasquale, RN

Phase Number:

I/II

General Eligibility:

Patient must be older than 39 years of age.Patients must have histologically confirmed adenocarcinoma of the breast, with the primary tumor < 4 cm and 0 - 3 positive axillary lymph nodes (pathologic T1-2, pathologic N0, N1, M0). Patients with squamous carcinomas or sarcomas of the breast cancer are NOT eligible. Patients must have undergone a segmental mastectomy with a level I and II axillary dissection or sentinel lymph node biopsy. Surgical margins at must be negative (>3 mm). Treatment must start within 6 weeks from surgery.Patients must NOT have received any prior trastuzumab (herceptin) therapy.No prior radiation therapy to the breast.No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for 5 years.Patients must not be pregnant.

Purpose:

To determine the potential early and late skin and subcutaneous side effects of partial breast irradiation given with chemotherapy. To determine the local control rate and cosmetic effect of partial breast irradiation, when given with chemotherapy.

Treatment:

Patients will receive Doxorubicin and Cyclophosphamide every two weeks for four cycles. Radiation therapy will begin on day 1 cycle 1 of chemotherapy. There will be 15 radiation treatments given Monday through Friday for three weeks.