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Radiation Therapy

Hypofractionated Radiation Therapy for Early-Stage Breast Cancer (NOVEMBER Trial)

Phase 2
Waitlist Available
Led By Matthew Poppe
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women of child-bearing potential must agree to utilize a form of birth control or agree to undergo sexual abstinence during radiation therapy
Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1
Must not have
Significant post lumpectomy complications requiring an unplanned re-operation or admission for intravenous (IV) antibiotics; re-operation for margins evaluation or nodal evaluation is acceptable
Co-existing medical conditions with life expectancy < 5 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at how well a shorter, high-dose radiation therapy works to treat early-stage breast cancer.

Who is the study for?
This trial is for women with stage 0-IIB breast cancer who can consent to treatment, use birth control or abstain from sex during therapy, and have a good performance status. They must not have had prior chest radiation, other recent cancers (except certain skin cancers or cervical carcinoma in situ), severe medical conditions, or collagen vascular diseases.
What is being tested?
The study tests hypofractionated radiation therapy on patients with early-stage breast cancer. This method uses higher doses over fewer sessions compared to traditional treatments and aims to be more effective with less side effects.
What are the potential side effects?
While the trial aims for fewer side effects due to its shorter duration of treatment, potential side effects may include skin irritation, fatigue, swelling in the treated area, and changes in breast texture.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use birth control or abstain from sex during radiation therapy.
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I am fully active or can carry out light work.
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My breast cancer diagnosis was confirmed through a biopsy.
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My radiation treatment is limited to the breast area, not beyond.
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My cancer is in the early stages and hasn't spread to lymph nodes or other parts of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had complications after a lumpectomy that needed more surgery or IV antibiotics.
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My other health conditions do not reduce my life expectancy to less than 5 years.
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I have an active collagen vascular disease like lupus, scleroderma, or dermatomyositis.
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I received chemotherapy before radiation treatment.
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My cancer is either a neuroendocrine carcinoma or sarcoma.
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I am taking medication to enhance the effects of radiation therapy, as advised by my doctor.
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I have had radiation therapy to my chest, neck, or armpit area.

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
Percentages of Participants by EORTC Breast Cosmetic Rating Score at 24 Months Post-radiation Therapy
Secondary study objectives
Cost-effectiveness (CE) of Hypofractionated Radiation Versus Standard Fractionation
Incidence of Acute and Late Radiation Complications Based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 Toxicity
Local and Local Regional Recurrence Rate
+2 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: TreatmentExperimental Treatment1 Intervention
Within 12 weeks after breast conserving surgery, patients undergo hypofractionated radiation therapy for 9 fractions over 2 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?

University of UtahLead Sponsor
1,141 Previous Clinical Trials
1,697,684 Total Patients Enrolled
15 Trials studying Breast Cancer
7,124 Patients Enrolled for Breast Cancer
Matthew PoppePrincipal InvestigatorHuntsman Cancer Institute/ University of Utah

Media Library

Hypofractionated Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03345420 — Phase 2
Breast Cancer Research Study Groups: Treatment
Breast Cancer Clinical Trial 2023: Hypofractionated Radiation Therapy Highlights & Side Effects. Trial Name: NCT03345420 — Phase 2
Hypofractionated Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03345420 — Phase 2
~13 spots leftby Nov 2025
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