This phase II trial studies how well hypofractionated radiotherapy before (preoperative) or after (postoperative) breast surgery works in treating patients with different types of non-metastatic (has not spread from original tumor site) breast cancer and to determine the outcomes and side effects of this treatment. Radiation therapy is considered an integral part of breast conserving therapy. Hypofractionated radiation therapy is a radiation treatment in which the total dose of radiation is divided into large doses and treatments are given less than once a day. This has been shown to be an effective treatment for breast cancer while reducing treatment time and decreasing side effects. Preoperative radiotherapy alone or concurrently with chemotherapy has also been tested with excellent results and with minimal toxicity. Preoperative radiation of the intact tumor with a hypofractionated regimen can potentially decrease toxicity by allowing the delivery of treatment to intact breast tissue. The potential advantages of preoperative radiation therapy include the delivery of radiation in the intact breast when radiation can be more effective as more oxygen can be available in the tissue. Furthermore, complications and cosmetic results are expected to be lower in pre-operative radiotherapy before surgery, as there have been no changes in blood supply to the breast. This lends to the possibility of using lower doses of radiotherapy to patients, and potentially better cancer associated clinical outcomes for our breast cancer patients. Undergoing hypofractionated radiation therapy before or after breast surgery may be safe and effective in treating patients with different types of non-metastatic breast cancer.
Age >= 18 years
Histological confirmation of breast cancer
Clinical stage T1-T4 N0-3 M0
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2
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 in the judgment of the principal investigator
Active systemic lupus or scleroderma
Parallel
Biopsy of Breast
Procedure/SurgeryUndergo breast biopsy
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Breast Surgery
Procedure/SurgeryUndergo breast surgery
Chemotherapy
DrugReceive SOC chemotherapy
Computed Tomography
Procedure/SurgeryUndergo CT
Contrast Enhanced Digital Mammography
Procedure/SurgeryUndergo CEDM
Hypofractionated Radiation Therapy
RadiationUndergo hypofractionated radiotherapy
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Positron Emission Tomography
Procedure/SurgeryUndergo PET
Survey Administration
Other interventionAncillary studies
Tissue Collection
Procedure/SurgeryUndergo tissue collection
Ultrasound Imaging
Procedure/SurgeryUndergo ultrasound
Incidence of grade 3 or higher radiation treatment (RT) related adverse events
Will assess the occurrence of grade 3 or higher RT related adverse events within years from the start of radiation therapy. Will be defined as an increase in the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 to grade 3+ compared to pre-radiation therapy. Adverse event rate will be defined as the proportion of patients experiencing the previously defined adverse events at any time from start of RT over the number of randomized patients included in the primary analysis population.
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