Hypofractionated Radiation Therapy in Treating Patients With Stage 0-IIB Breast Cancer (NOVEMBER)

December 9, 2025 updated by: University of Utah

NOVEMBER (Novem- (9), BrEast Radiation), A Phase II Trial of a 9 Day Course of Whole Breast Radiotherapy for Early Stage Breast Cancer

This phase II trial studies how well hypofractionated radiation therapy works in treating patients with stage 0-IIB breast cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Adjuvant radiation therapy (RT) plays an important role in successful breast conservation in early-stage breast cancer and has been shown to significantly reduce the risk of breast cancer recurrence over surgery alone. Adding breast radiation to lumpectomy has allowed women to keep their natural breast, as multiple randomized trials have demonstrated equivalent overall and disease-free survival compared to a mastectomy. Meta-analyses have concluded that post-lumpectomy radiation improves breast cancer survival, with an estimated 1 life saved for every 4 recurrences prevented. An important component of radiation therapy is the time-dose-fractionation schedule. Up until the last decade, the standard radiation schedule in North America involved 6-8 weeks of daily radiation.

This study proposes that fractionation will provide a significant improvement in convenience and cost effectiveness, while delivering equivalent cancer control.

This will be a phase II single arm non-inferiority trial. Trial patients will receive 9 fractions hypofractionated radiation. Patients will be evaluated for breast photographic cosmetic scores with hypofractionated radiation compared to standard fractionation 24 months after radiation.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute/University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed invasive carcinoma and/or ductal carcinoma in situ (DCIS) of the breast
  • Final pathologic Tis, T1-T3, all must be N0 and M0 status.
  • Negative inked histologic margins from lumpectomy, with the exception of a focus of positive margin at the pectoralis fascia
  • Radiation oncologist does not plan to treat regional lymph nodes beyond standard whole breast tangent fields
  • Lumpectomy with negative lymph node on surgical evaluation (Isolated tumor cells in lymph nodes will be permitted). Patients with invasive carcinoma ≥ 70 yrs and with ER+ positive tumor ≤ 2.0cm may enroll without surgical lymph node evaluation, per section 5.1. Patients with Ductal Carcinoma In Situ (DCIS) of the breast only may enroll without surgical lymph node evaluation.

  • Negative serum or urine beta-human chorionic gonadotropin (HCG) in women of child-bearing potential =< 7 days prior to registration

    • A female of childbearing potential is a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 12 consecutive months
  • 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
  • Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

Exclusion Criteria:

  • Prior radiation therapy to the chest, neck or axilla
  • Prior history of ipsilateral breast cancer (invasive disease or DCIS); lobular carcinoma in situ (LCIS) and benign breast disease is allowed
  • History of prior or concurrent contralateral invasive breast cancer; benign breast disease, LCIS or DCIS of contralateral breast is allowed
  • Active collagen vascular diseases, such as: systemic lupus erythematous, scleroderma, or dermatomyositis
  • 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
  • Other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix
  • Neoadjuvant chemotherapy or adjuvant chemotherapy delivered before radiation
  • Neuroendocrine carcinoma or sarcoma histology
  • Concurrent radiation sensitizing medications concurrent with radiation, per treatment physician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Within 12 weeks after breast conserving surgery, patients undergo hypofractionated radiation therapy for 9 fractions over 2 weeks.
Radiation: Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
Other Names:
  • Hypofractionated Radiotherapy
  • hypofractionation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentages of Participants by EORTC Breast Cosmetic Rating Score at 24 Months Post-radiation Therapy
Time Frame: Up to 24 months post radiation therapy (RT)
The EORTC (European Organisation for Research and Treatment of Cancer) Breast Cosmetic Rating system is a blinded digital photographic method that compares the radiated breast with the contralateral untreated side and evaluates: Size, shape, location of the areola/nipple, appearance of the surgical scar, skin pigmentation changes, presence of telangiectasia and a global cosmetic score based on all of the factors. Characteristics are graded on a four-point scale: 0, excellent or no difference; 1, good or small difference; 2, fair or moderate difference; and 3, poor or large difference. Images taken at the 24 month timepoint were assessed by 3 unbiased reviewers including a radiation oncologist, surgeon and nurse. The data is presented as the count of participants meeting the overall rating criteria as assessed by these reviewers.
Up to 24 months post radiation therapy (RT)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life as Measured by Breast-Q Questionnaire Scores at 6 Month Post-RT Timepoint
Time Frame: 6 months post RT
  • Assessed 4 subscales: satisfaction with breasts, psychosocial well-being, physical well-being, and sexual well-being.
  • Score from 0 (worst) to 100 (best). Higher scores reflect a better outcome.
6 months post RT
Quality of Life as Measured by Breast-Q Questionnaire Scores at 24 Month Post-RT Timepoint
Time Frame: 24 months post RT
  • Assessed 4 subscales: satisfaction with breasts, psychosocial well-being, physical well-being, and sexual well-being.
  • Score from 0 (worst) to 100 (best). Higher scores reflect a better outcome.
24 months post RT
Incidence of Acute and Late Radiation Complications Based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 Toxicity
Time Frame: Up to 5 years
The proportion of patients with acute or late radiation complications, will be estimated. Any event longer than 3 months will be considered a late effect.
Up to 5 years
Local and Local Regional Recurrence Rate
Time Frame: Up to 60 months
We will report the incidence of recurrence
Up to 60 months
Cost-effectiveness (CE) of Hypofractionated Radiation Versus Standard Fractionation
Time Frame: Up to 3 years
Will be explored using cost data and quality adjusted life years (QALYs)
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Matthew Poppe, Huntsman Cancer Institute/ University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2017

Primary Completion (Actual)

August 30, 2022

Study Completion (Actual)

June 26, 2025

Study Registration Dates

First Submitted

November 6, 2017

First Submitted That Met QC Criteria

November 13, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Estimated)

December 30, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCI103976 (Other Identifier: Huntsman Cancer Institute/University of Utah)
  • NCI-2017-02018 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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