Hypofractionated Radiation Therapy for Patients With Breast Cancer Receiving Regional Nodal Irradiation

Participants with stage II or stage III node-positive breast cancer, or T3N0 node-negative
will receive hypofractionated radiation for 4 weeks. We hypothesize that patients receiving a
shorter course of radiation will have reduced lymphedema. Lymphedema is diagnosed when the
patient's arm circumference measures 10% or more as compared to pre-treatment (baseline) arm
circumference measurement. Secondary endpoints will address the effectiveness, quality of
life, and side effect profile of a shortened course of treatment.

Inclusion Criteria:

- Karnofsky Performance Status 50% - 100%

- Diagnosis of stage II or III node-positive breast cancer (NOTE: Stages include:
T4a-cNany, T3N1, TxN2.) OR T3N0 node-negative breast cancer.

- For patients with TxN1 disease, one of the following criteria must be met: Grade 3; ≤
45 years of age at time of screening for this study; extensive Lymphovascular Space
Invasion (LVSI); 3 lymph nodes positive; hormone-negative disease; positive lymph
nodes after chemotherapy; or extracapsular extension

- Prior surgery and chemotherapy allowed, no prior radiation to the target area (breast
or chest and nodes). NOTE: Radiation should occur 3-12 weeks after last chemotherapy
or surgery, whichever comes last.

- Women of child-bearing potential (WOCP) must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry, for
the duration of study participation, and for 90 days following completion of therapy.

Exclusion Criteria:

- Diagnosis of inflammatory breast cancer

- Previously diagnosed malignancy excluding basal or squamous cell carcinoma of the skin
(unless disease-free for 5 years or more)

- Diagnosis of scleroderma

- Diagnosis of lupus

- Diagnosis of active dermatomyositis

- Diagnosis of metastatic disease

- Pregnant or nursing