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Radiation Therapy

Hypofractionated Radiation Therapy for Breast Cancer

Phase 3
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No prior therapeutic radiation therapy to the chest, neck or axilla; prior radioactive oral iodine is permitted
Negative inked histologic margins from mastectomy pathology (no invasive cells at margin). Patients with DCIS at margin are eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is testing how well higher doses of radiation therapy over a shorter period of time works to prevent cancer recurrence in patients who have undergone mastectomy.

Who is the study for?
This trial is for women with stage IIa-IIIa breast cancer who've had a mastectomy. They must not be pregnant, have no history of certain other cancers or severe diseases, and agree to birth control if of childbearing potential. Participants should not have received prior chest radiation and must plan to start treatment within specific timeframes.
What is being tested?
The study tests hypofractionated radiation therapy, which uses higher doses over a shorter period than traditional radiation, after mastectomy to prevent cancer recurrence. It includes lab biomarker analysis and quality-of-life assessments.
What are the potential side effects?
Potential side effects may include skin irritation, fatigue, swelling in the treated area, changes in breast appearance or sensation, and rare risks like heart problems or secondary cancers due to increased radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't had radiation therapy to my chest, neck, or armpit area; but I may have had radioactive iodine treatment.
Select...
My mastectomy showed no cancer cells at the edges of the removed tissue.
Select...
I do not have any active collagen vascular diseases like lupus.
Select...
My breast cancer is confirmed and not metaplastic.
Select...
I have never had breast cancer or DCIS in the same breast before, but benign conditions are okay.
Select...
My tissue expander is filled with fluid, not air, if I'm undergoing radiation therapy.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My radiation treatment does not include a boost to the chest wall or scar.
Select...
My breast cancer is at an early stage and has not spread to distant parts of my body.
Select...
I do not have any health conditions that could shorten my life to under 5 years.

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
Rate of breast reconstruction complications
Secondary study objectives
Economic analyses
Incidence of acute and late radiation complications based on Common Terminology Criteria for Adverse Events 4.0 toxicity
Incidence of arm lymphedema as measured by percent change in ipsilateral arm volume post-radiation from its pre-radiation volume
+7 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

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group II (hypofractionated radiation therapy)Experimental Treatment4 Interventions
Patients undergo hypofractionated radiation therapy daily on Monday-Friday for 3-4 weeks.
Group II: Group I (radiation therapy)Active Control4 Interventions
Patients undergo radiation therapy daily on Monday-Friday for 5-6 weeks.
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?

Alliance for Clinical Trials in OncologyLead Sponsor
518 Previous Clinical Trials
221,500 Total Patients Enrolled
5 Trials studying Breast Carcinoma
4,018 Patients Enrolled for Breast Carcinoma
National Cancer Institute (NCI)NIH
13,920 Previous Clinical Trials
41,016,037 Total Patients Enrolled
105 Trials studying Breast Carcinoma
46,575 Patients Enrolled for Breast Carcinoma
Canadian Cancer Trials GroupNETWORK
132 Previous Clinical Trials
68,970 Total Patients Enrolled
1 Trials studying Breast Carcinoma
3,177 Patients Enrolled for Breast Carcinoma

Media Library

Hypofractionated Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03414970 — Phase 3
Breast Carcinoma Research Study Groups: Group II (hypofractionated radiation therapy), Group I (radiation therapy)
Breast Carcinoma Clinical Trial 2023: Hypofractionated Radiation Therapy Highlights & Side Effects. Trial Name: NCT03414970 — Phase 3
Hypofractionated Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03414970 — Phase 3
~22 spots leftby Feb 2025
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