Hypofractionated Radiation Therapy in Treating Patients With Stage 0-IIB Breast Cancer
Hypofractionated Radiation Therapy in Treating Patients With Stage 0-IIB Breast Cancer
This phase II trial studies how well hypofractionated radiation therapy works in treating
 patients with stage 0-IIB breast cancer. Hypofractionated radiation therapy delivers higher
 doses of radiation therapy over a shorter period of time and may kill more tumor cells and
 have fewer side effects.
PRIMARY OBJECTIVES:

 I. To evaluate 24 month breast photographic cosmetic scores with 9 fraction radiation
 compared to standard hypofractionation.

 SECONDARY OBJECTIVES:

 I. To evaluate Breast-Q patient reported outcomes (PROs) compared to historical control in
 breast conservation.

 II. To evaluate the incidence of acute and late radiation complications, based on Common
 Terminology Criteria for Adverse Events (CTCAE) 4.0 toxicity.

 III. To evaluate the local and local regional recurrence rate. IV. To compare the direct and
 indirect patient costs for radiation therapy compared to historical controls as well as
 quality adjusted life years, utilizing the Breast-Q Patient Reported Outcomes (PROs) and the
 EQ-5D.

 OUTLINE:

 Within 12 weeks after breast conserving surgery, patients undergo hypofractionated radiation
 therapy for 9 fractions over 2 weeks.

 After completion of study treatment, patients are followed up at 2-8 weeks, 6 months, and
 annually for 3 years.
Inclusion Criteria:

 -  Histologically confirmed invasive carcinoma and/or ductal carcinoma in situ (DCIS) of
 the breast

 -  Final pathologic Tis, T1-T3, all must be N0 and M0 status.

 -  Negative inked histologic margins from lumpectomy, with the exception of a focus of
 positive margin at the pectoralis fascia

 -  Radiation oncologist does not plan to treat regional lymph nodes beyond standard whole
 breast tangent fields

 -  Lumpectomy with negative lymph node on surgical evaluation (Isolated tumor cells in
 lymph nodes will be permitted). Patients with invasive carcinoma ≥ 70 yrs and with ER+
 positive tumor ≤ 2.0cm may enroll without surgical lymph node evaluation, per section
 5.1. Patients with Ductal Carcinoma In Situ (DCIS) of the breast only may enroll
 without surgical lymph node evaluation.

 -  Negative serum or urine beta-human chorionic gonadotropin (HCG) in women of
 child-bearing potential =< 7 days prior to registration

 -  A female of childbearing potential is a sexually mature female who has not
 undergone a hysterectomy or bilateral oophorectomy and has not been naturally
 postmenopausal for at least 12 consecutive months

 -  Women of child-bearing potential must agree to utilize a form of birth control or
 agree to undergo sexual abstinence during radiation therapy

 -  Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1

 -  Able to provide informed consent and willing to sign an approved consent form that
 conforms to federal and institutional guidelines

 Exclusion Criteria:

 -  Prior radiation therapy to the chest, neck or axilla

 -  Prior history of ipsilateral breast cancer (invasive disease or DCIS); lobular
 carcinoma in situ (LCIS) and benign breast disease is allowed

 -  History of prior or concurrent contralateral invasive breast cancer; benign breast
 disease, LCIS or DCIS of contralateral breast is allowed

 -  Active collagen vascular diseases, such as: systemic lupus erythematous, scleroderma,
 or dermatomyositis

 -  Significant post lumpectomy complications requiring an unplanned re-operation or
 admission for intravenous (IV) antibiotics; re-operation for margins evaluation or
 nodal evaluation is acceptable

 -  Co-existing medical conditions with life expectancy < 5 years

 -  Other malignancy within 5 years of registration with the exception of basal cell or
 squamous cell carcinoma of the skin treated with local resection only or carcinoma in
 situ of the cervix

 -  Neoadjuvant chemotherapy or adjuvant chemotherapy delivered before radiation

 -  Neuroendocrine carcinoma or sarcoma histology

 -  Concurrent radiation sensitizing medications concurrent with radiation, per treatment
 physician