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Radiation Therapy

Radiation Therapy for Breast Cancer

Phase 2
Waitlist Available
Led By Carlos E. Vargas, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histological confirmation of breast cancer
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2
Must not have
Medical contraindication to receipt of radiotherapy
No neo-adjuvant therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trialstudies a new form of radiation therapy to treat breast cancer before surgery that may work better and have fewer side effects.

Who is the study for?
This trial is for individuals with confirmed breast cancer, clinical stage T0-T2 N0 M0, who can consent and complete tests. They must be able to visit the institution for follow-up and are planning surgery with whole breast radiotherapy. It's not for pregnant women, those not using contraception, prior chest radiation patients, recurrent cancer cases or people with severe illnesses.
What is being tested?
The study is examining hypofractionated radiation therapy before surgery in breast cancer patients. This method involves higher doses of radiation over a shorter period than traditional treatments, potentially improving tumor control with fewer side effects.
What are the potential side effects?
While specific side effects aren't listed here, hypofractionated radiation generally may cause skin irritation at the treatment site, fatigue, mild swelling or tenderness in the treated area. The approach aims to reduce overall side effects compared to conventional radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer has been confirmed through a biopsy.
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I can take care of myself and am up and about more than half of my waking hours.
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I am scheduled for breast surgery and will need radiation therapy for my whole breast.
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My cancer is in an early stage and has not spread to lymph nodes or other parts of the body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot undergo radiotherapy due to health reasons.
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I have not received any initial treatment before the main therapy.
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I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.
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I have had radiation therapy on the same side breast or chest before.
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My breast cancer has come back.
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I have active lupus or scleroderma.
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I am a woman who can have children and do not plan to use birth control.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pathologic Complete Response (pCR) Rate Defined as a Residual Tumor Burden of 0-1 in the Surgical Specimen
Secondary study objectives
Cause-specific Survival
Disease- Free Survival
Incidence of Late Adverse Events
+4 more
Other study objectives
Clinical Features, Treatment Technique, Dose-volume Parameters, Histologic and Genetic Variants
Panel Assessed Cosmetic Outcome
Pathologic Changes Seen in Breast Cancer Patients With Preoperative Radiation
+3 more

Side effects data

From 2023 Phase 3 trial • 107 Patients • NCT03324802
80%
Dermatitis radiation
54%
Skin hyperpigmentation
48%
Pain
35%
Lymphedema
22%
Superficial soft tissue fibrosis
7%
Skin hypopigmentation
6%
Edema limbs
2%
Device related infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1 (Radiation Therapy, 15 Fractions)
Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (hypofractionated radiation therapy)Experimental Treatment1 Intervention
Participants undergo hypofractionated radiation therapy daily for 5 days, then undergo standard of care surgery 4-16 weeks after radiation therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 3
~130

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,907 Previous Clinical Trials
41,012,119 Total Patients Enrolled
942 Trials studying Breast Cancer
1,443,255 Patients Enrolled for Breast Cancer
Mayo ClinicLead Sponsor
3,326 Previous Clinical Trials
3,059,469 Total Patients Enrolled
84 Trials studying Breast Cancer
14,796 Patients Enrolled for Breast Cancer
Carlos E. Vargas, M.D.Principal InvestigatorMayo Clinic
5 Previous Clinical Trials
397 Total Patients Enrolled

Media Library

Hypofractionated Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03624478 — Phase 2
Breast Cancer Research Study Groups: Treatment (hypofractionated radiation therapy)
Breast Cancer Clinical Trial 2023: Hypofractionated Radiation Therapy Highlights & Side Effects. Trial Name: NCT03624478 — Phase 2
Hypofractionated Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03624478 — Phase 2
~4 spots leftby Nov 2025
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