Hypofractionated Radiation Therapy in Treating Participants With Breast Cancer Before Surgery

Completed · Phase 2

Conditions studied: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8

In brief

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.

Key facts

Study ID

NCT03624478

Run by

Mayo Clinic

People needed

25

Starts

2018-11-20

Expected to finish

2025-09-24

Last updated by the study team

2026-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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