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Radiation Therapy

Hypofractionated Radiation Therapy for Breast Cancer

Phase 2
Waitlist Available
Led By Carlos Vargas
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial looks at whether a higher dose of radiation over a shorter time period is more effective at preventing tumor cell return in breast cancer patients post-surgery, and whether it has fewer side effects.

Eligible Conditions
  • Stage IIA Breast Cancer
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complication Rate, Defined as the Percentage of Women Who Develop Grade 3 or Higher Late Adverse Event and/or Deterioration of Cosmesis From Excellent/Good to Fair/Poor or From Fair to Poor
Secondary outcome measures
Cause-specific Survival
Disease- Free Survival
Distant Recurrence Defined as Metastatic Cancer That Has Either Been Biopsy Confirmed or Clinically Diagnosed as Recurrent Invasive Breast Cancer
+5 more
Other outcome measures
Patient Reported Outcomes/Quality of Life
Patient Self-reported Cosmesis

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm I (radiation therapy, 15 fractions)Experimental Treatment2 Interventions
Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days.
Group II: Arm 2 (hypofractionated radiation therapy, 5 fractions)Experimental Treatment2 Interventions
Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 5 daily fractions for 5 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~130
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,234 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,343 Patients Enrolled for Breast Cancer
Mayo ClinicLead Sponsor
3,191 Previous Clinical Trials
3,758,404 Total Patients Enrolled
83 Trials studying Breast Cancer
14,046 Patients Enrolled for Breast Cancer
Carlos VargasPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
25 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~15 spots leftby Mar 2025