Protocol Title:

A Feasibility Trial of Partial Breast Irradiation with Various Concurrent Chemotherapy Regimens (PBIC)

Protocol Status:

Pending

Protocol Number:

J-0805

Type of Cancer:

Breast Cancer

Principal Investigator:

Richard Zellars, M.D.

Research Nurse:

Shirl DiPasquale, R.N.

Phase Number:

Feasibility Trial

General Eligibility:

All females greater than or equal to 18 years of age with confirmed adenocarcinoma of the breast may join. Patient must have had a bilateral mammogram prior to surgery.
Patients must have undergone a segmental mastectomy (SM) with a level I and ll axillary dissection or sentinel lymph node biopsy. Surgical margins at time of SM must be negative (> or = 2 mm) for both invasive carcinoma and for non-invasive ductal carcinoma. Patients who have post-operative margins which are negative but less than 2mm will be considered eligible if the surgeon states that the margin in question could not be improved. Patients must be registered such that radiation therapy begins no sooner than 7 days prior to, but no later than 7 days after, day 1 of cycle (C1D1). Patient must start chemotherapy and radiation less than 14 weeks from the last breast surgical procedure. Patients can not have received neoadjuvant chemotherapy or radiotherapy in the past. Prior malignancies are acceptable but limited.

Purpose:

Primary:
To assess the potential acute and late skin and subcutaneous    
toxicities of partial breast irradiation concurrent with chemotherapy.
Secondary:
To assess cosmetic effect of PBIC and to assess local control rate of patients treated with PBIC.

Treatment:

The chemotherapeutic regimen will be chosen by the patient and her medical oncologist. The dosing schedule for each available regimen is listed in Appendix I. Radiation therapy may start up to 7 days before but no later than 7 days after C1D1. There will be 15 weekday treatments of radiation therapy. A total of 34 patients will be accrued. Patients will receive radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy.