The primary objective of this study is to document lymphedema rates in patients requiring
regional nodal irradiation (RNI) who receive hypofractionated radiation as compared to
- 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.
- 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