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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Hypofractionated Radiation Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypofractionated Radiation Therapy<br>Daily for 4 weeks | Radiation: Hypofractionated Radiation Therapy<br>* Chest/Breast 4005 centigray (cGy)/15 fractions/267 cGy daily Regional nodes 4005 cGy/15 fractions/267 cGy daily 1000 cGy boost to lumpectomy/scar/undissected nodes 200 cGy daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymphedema Rate | Defined as a 10% increase in arm circumference from pre-treatment (baseline) arm circumference measurement. | One year post end of treatment (EOT) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Recurrence | Defined as biopsy proven recurrence of breast cancer involving the chest wall, breast, axilla, internal mammary or supraclavicular nodes | 12 months post-EOT | 
| Cosmetic (Breast) Outcome | Measured using the Breast Q™ Assessment questionnaire | 12 months post-EOT | 
| Quality of Life | Measured using the Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B+4) questionnaire | After enrollment but prior to CT simulation; 14-90 days post-EOT; 12 months post-EOT | 
| Range of Motion (Upper Extremities) | Percent reduction in referrals to physical therapy for impaired range of movement post-EOT | 14-90 days post-EOT; 6 months post-EOT; 12 months post-EOT |