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

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
conventional radiation.

Eligibility Criteria

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

Principal Investigator

Melissa Mitchell, MD

Study Contact

Leah Miller 913-588-3670

Estimated Completion Date

Thursday, October 31, 2019

ClinicalTrials.gov #

NCT02958774
11/05/2017