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

NCT03345420 | Completed Phase 2 Results DMC FDA Device

• 2 other identifiers: HCI103976NCI-2017-02018
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Invasive Breast Carcinoma; Stage 0 Breast Cancer; Stage I Breast Cancer; Ductal Breast Carcinoma In Situ; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Percentages of Participants by EORTC Breast Cosmetic Rating Score at 24 Months Post-radiation Therapy

  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 Outcomes (5)

• Quality of Life as Measured by Breast-Q Questionnaire Scores at 6 Month Post-RT Timepoint

  6 months post RT

• Quality of Life as Measured by Breast-Q Questionnaire Scores at 24 Month Post-RT Timepoint

  24 months post RT

• Incidence of Acute and Late Radiation Complications Based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 Toxicity

  Up to 5 years

• Local and Local Regional Recurrence Rate

  Up to 60 months

• Cost-effectiveness (CE) of Hypofractionated Radiation Versus Standard Fractionation

  Up to 3 years

Study Arms (1)

Treatment

EXPERIMENTAL

Within 12 weeks after breast conserving surgery, patients undergo hypofractionated radiation therapy for 9 fractions over 2 weeks.

Radiation: Hypofractionated Radiation Therapy

Interventions

Hypofractionated Radiation Therapy RADIATION

Undergo hypofractionated radiation therapy

Also known as: Hypofractionated Radiotherapy, hypofractionation

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (40)

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Related Links

• NOVEMBER, A Phase 2 Trial of a 9-Day Course of Whole Breast Radiation Therapy With a Simultaneous Lumpectomy Boost for Early-Stage Breast Cancer

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Breast Carcinoma In Situ; Breast Neoplasms

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Clinicaltrials.gov/CTRP Specialist
• Organization: Huntsman Cancer Institute/University of Utah

IITDataManagement@hci.utah.edu

8012136215

Study Officials

• Matthew Poppe

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 17, 2017
• Study Start: December 12, 2017
• Primary Completion: August 30, 2022
• Study Completion: June 26, 2025
• Last Updated: December 30, 2025
• Results First Posted: February 6, 2024

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)