Actively Recruiting
A Randomized Phase II Trial of Hypofractionated Radiotherapy for Non-Metastatic Breast Cancer Before or After Breast Surgery for Different Breast Cancer Risk Groups
Led by Mayo Clinic · Updated on 2025-12-12
120
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how well hypofractionated radiotherapy given before or after breast surgery works for patients with different types of non-metastatic breast cancer. This phase II trial aims to compare the safety and side effects of preoperative versus postoperative radiation therapy and to study various outcomes including tumor response, wound healing, and long-term cancer control. Radiation therapy is an important part of breast cancer treatment, and this study explores how delivering it in larger doses over fewer treatments may reduce side effects and improve results. Participants are assigned to one of two groups: one group receives standard chemotherapy followed by hypofractionated radiation therapy before breast surgery, while the other group has chemotherapy and surgery first, then radiation therapy. Radiation therapy is given once daily for a total of five treatments. Throughout the study, patients undergo imaging tests including CT, MRI, PET, digital mammography, and ultrasound. Biopsies and optional blood and tissue samples are also collected to study tumor biology and treatment effects. During the study, patients are monitored at several time points including 16 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years after treatment begins. Researchers assess adverse events related to radiation, wound healing complications, cancer control, patient-reported outcomes, and cosmetic results. They also analyze tumor mutations and immune responses before and after treatments. This thorough follow-up helps evaluate both the safety and the effectiveness of the radiation timing approaches in breast cancer care.
CONDITIONS
Brief Title
Hypofractionated Radiotherapy Before or After Breast Surgery for Treatment of Patients With Non-Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histological confirmation of breast cancer
- Clinical stage T1-T4 N0-3 M0
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Ability to provide informed consent approved by Institutional Review Board
- Ability to complete all mandatory tests listed in the trial
- Willingness to return to the enrolling institution for follow-up
- Indications for radiotherapy for breast cancer
You will not qualify if you...
- Medical contraindication to radiation therapy
- Severe active co-morbid systemic illnesses or other severe concurrent disease
- Uncontrolled illness including infection, heart failure, unstable angina, arrhythmia, or psychiatric/social issues
- Active systemic lupus or scleroderma
- Pregnancy
- Women of childbearing potential unwilling to use adequate contraception
- Previous radiation to the same breast or chest wall
- Recurrent breast cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants undergo mandatory tests including biopsies and imaging to confirm eligibility.
Duration - Approximately 10 weeks from start of radiotherapy to surgery in Arm I; chemotherapy and surgery followed by radiotherapy in Arm II, total duration varies.
Participants receive standard chemotherapy and hypofractionated radiotherapy either before or after breast surgery depending on their assigned arm.
Radiotherapy involves 5 daily treatments; participants also undergo multiple imaging visits including CT, MRI, PET, CEDM, and ultrasound throughout treatment.
Duration - Up to 5 years after treatment completion
Participants are monitored for adverse events, disease control, and patient-reported outcomes after completion of treatment.
Follow-up visits occur at 16 weeks, 6 months, 12 months, 24 months, 36 months, 48 months, and 5 years.
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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