Breast Cancer Clinical Trial
Hypofractionated Radiation Therapy in Treating Participants With Breast Cancer Before Surgery
Summary
This phase II trial studies how well hypofractionated radiation therapy works in treating participants with breast cancer before surgery. 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.
Full Description
PRIMARY OBJECTIVES:
I. To determine the pathologic complete response (pCR) rate after hypofractionated radiotherapy to the whole breast alone, based on the postsurgical specimen.
SECONDARY OBJECTIVES:
I. To evaluate acute and late toxicity with preoperative radiation including grade >= 2 pneumonitis.
II. To estimate the 5-year locoregional control, distant recurrence, invasive disease-free survival, cause-specific survival, and overall survival.
CORRELATIVE AND EXPLORATORY OBJECTIVES:
I. To evaluate patient-reported outcomes. II. To evaluate clinical features, treatment technique, dose-volume parameters, histologic and genetic variants associated with adverse events, and fair and poor cosmetic outcomes or unplanned surgical intervention.
III. Evaluate tumor mutation signatures before and after radiation; correlate tumor mutation signatures before and after radiation with pathologic information at the time of surgery.
IV. To describe the pathologic changes seen in breast cancer patients with preoperative radiation.
OUTLINE:
Participants undergo hypofractionated radiation therapy daily for 5 days, then undergo standard of care surgery 4-16 weeks after radiation therapy.
After completion of study treatment, participants are followed up at 12 weeks, 6, 12, 24, and 36 months, and 5 years after radiation therapy.
Eligibility Criteria
Inclusion Criteria:
Histological confirmation of breast cancer
Clinical stage T0-T2 N0 M0
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 120 days of last biopsy (breast)
Able to complete all mandatory tests
Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
Planned breast 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
Women of childbearing potential who are unwilling to employ adequate contraception
Prior receipt of ipsilateral breast or chest wall radiation
Recurrent breast cancer
Indications for comprehensive regional nodal irradiation
No neo-adjuvant therapy
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There are 3 Locations for this study
Scottsdale Arizona, 85259, United States
Jacksonville Florida, 32224, United States
Rochester Minnesota, 55905, United States
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