Hypofractionated Radiation Therapy for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Breast Cancer+7 More
Hypofractionated Radiation Therapy - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

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
  • Breast Cancer
  • Malignant neoplasm of breast
  • Breast

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Up to 5 years

24 months
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
Year 5
Patient self-reported cosmesis
Year 5
Overall survival
Year 5
Cause-specific survival
Year 5
Disease- free survival
Year 5
Invasive disease-free
Day 180
Incidence of acute adverse events (AEs)
Up to 5 years
Distant recurrence defined as metastatic cancer that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer
Locoregional control
Patient reported outcomes/quality of life
Year 5
Incidence of late adverse events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Arm 2 (hypofractionated radiation therapy, 5 fractions)
1 of 2
Arm I (radiation therapy, 15 fractions)
1 of 2
Experimental Treatment

82 Total Participants · 2 Treatment Groups

Primary Treatment: Hypofractionated Radiation Therapy · No Placebo Group · Phase 2

Arm 2 (hypofractionated radiation therapy, 5 fractions)Experimental Group · 2 Interventions: Hypofractionated Radiation Therapy, Quality-of-Life Assessment · Intervention Types: Radiation, Other
Arm I (radiation therapy, 15 fractions)Experimental Group · 2 Interventions: Radiation Therapy, Quality-of-Life Assessment · Intervention Types: Radiation, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~20
Radiation Therapy
2005
Completed Phase 3
~7080

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
12,990 Previous Clinical Trials
41,298,806 Total Patients Enrolled
923 Trials studying Breast Cancer
1,535,609 Patients Enrolled for Breast Cancer
Mayo ClinicLead Sponsor
2,892 Previous Clinical Trials
3,698,655 Total Patients Enrolled
84 Trials studying Breast Cancer
17,027 Patients Enrolled for Breast Cancer
Carlos VargasPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
25 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The study entry must be within 12 weeks of your last surgery (either breast or axilla surgery) or your last chemotherapy treatment (if you are applicable for this study).
This individual is able to complete all of the mandatory tests required in order to be employed.
The patient has a pathologic stage of T0-T3N0-N1M0
The Eastern Cooperative Oncology Group (ECOG) has defined performance status (PS) 0 to 2 as being fully active, able to carry out all usual activities.
from all individuals or their legally authorized representative(s) prior to any participation in the research
I am willing to return to the institution where I am enrolled for follow-up during the active monitoring phase of the study.
You have good or excellent cosmesis, as determined by trained nurse assessment using the Harvard Cosmetic Scale.
Radiotherapy must begin within 12 weeks of the last breast cancer surgery or the last dose of adjuvant chemotherapy.
Whole breast radiotherapy is a type of radiation therapy that is used to treat cancer that has spread, or is likely to spread, to the entire breast

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 22nd, 2021

Last Reviewed: October 27th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.