Hypofractionated Radiation Therapy in Treating Patients With Stage 0-IIB Breast Cancer

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 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