Hypofractionated Radiation Therapy in Preventing Recurrence in Patients With Breast Cancer After Surgery

PRIMARY OBJECTIVES:

I. To determine the 24-month complication rate of 5 fraction whole radiotherapy +/-
concurrent boost as compared to 15 fraction radiotherapy +/- sequential boost.

SECONDARY OBJECTIVES:

I. To evaluate acute and late toxicity. II. To estimate the 5-year locoregional control,
invasive disease-free survival and overall survival.

TERTIARY OBJECTIVES:

I. To evaluate fatigue, and other patient-reported outcomes. II. To evaluate clinical
features, treatment technique, dose-volume parameters, histologic and genetic variants
associated with fair and poor cosmetic outcomes or unplanned surgical intervention.

III. To evaluate the costs and comparative effectiveness of treatment. IV. Compare the use of
photon therapy with spot scanning proton therapy in two different hypo-fractionated whole
breast schemas.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo
radiation therapy in 15 daily fractions for 10 days.

ARM II: Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo
hypofractionated radiation therapy in 5 daily fractions for 5 days.

After completion of study treatment, patients are followed up to 5 years.

Inclusion Criteria:

- Histological confirmation of breast cancer

- Pathologic stage T0-T3N0-N1M0

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2

- Able to and provides Institutional Review Board (IRB) approved study specific written
informed consent

- Study entry must be within 12 weeks of last surgery (breast or axilla) or last
chemotherapy (if applicable)

- Able to complete all mandatory tests

- Willing to return to enrolling institution for follow-up (during the active monitoring
phase of the study)

- Fair, good or excellent cosmesis, as determined by trained nurse assessment using the
Harvard Cosmetic Scale

- Radiotherapy must begin within 12 weeks of the last breast cancer surgery or the last
dose of adjuvant chemotherapy

- Breast conserving surgery and indications for whole breast radiotherapy

Exclusion Criteria:

- Medical contraindication to receipt of radiotherapy

- Severe active co-morbid systemic illnesses or other severe concurrent disease which,
in the judgment of the investigator, would make the patient inappropriate for entry
into this study or interfere significantly with the proper assessment of safety and
toxicity of the prescribed regimens

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements or providing informed consent

- Active systemic lupus or scleroderma

- Pregnancy

- Prior receipt of ipsilateral breast or chest wall radiation

- Positive margins on ink after definitive surgery either for ductal carcinoma in situ
(DCIS) or invasive cancer

- History of non-breast malignancies (except for in situ cancers treated only by local
excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior
study entry

- Recurrent breast cancer

- Indications for comprehensive regional nodal irradiation