Preoperative Single-Fraction Radiotherapy in Early Stage Breast Cancer

NCT02482376 | Active Not Recruiting Phase 2 Results

• 1 other identifier: Pro00063848
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol seeks to build on the favorable results of the investigators' phase I trial (Pro00015617) by extending the findings to a larger cohort of subjects.In this study, the investigators hypothesize that 21Gy (Gray) as a single fraction can be delivered preoperatively to a larger group of subjects (n100). The primary objective is to determine physician reported rates of good/excellent cosmesis at baseline and 6 months, 1, 2, and 3 years post-treatment as measured by the NRG cosmesis scale

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Physician Reported Rates of Good/Excellent Cosmesis

  Physician will independently complete the physician NRG Oncology cosmesis scale at the designated time points. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.

  6 months

• Number of Participants With Physician Reported Rates of Good/Excellent Cosmesis

  Physician will independently complete the physician NRG Oncology cosmesis scale at the designated time points. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.

  1 year

• Number of Participants With Physician Reported Rates of Good/Excellent Cosmesis

  Physician will independently complete the physician NRG Oncology cosmesis scale at the designated time points. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.

  2 years

• Number of Participants With Physician Reported Rates of Good/Excellent Cosmesis.

  Physician will independently complete the physician NRG Oncology cosmesis scale at the designated time points. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.

  3 years

Secondary Outcomes (6)

• Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis

  baseline

• Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis

  6 months

• Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis

  12 months

• Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis

  2 year

• Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis

  3 year

Study Arms (1)

Single arm 21Gy stereotactic radiotherapy

OTHER

Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery.

Radiation: Stereotactic body radiotherapy ( SBRT)

Interventions

Stereotactic body radiotherapy ( SBRT) RADIATION

Single fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer

Also known as: SBRT

Single arm 21Gy stereotactic radiotherapy

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast
• a. Biopsy tissue (either slides or block) from outside institutions will be reviewed to confirm diagnosis.
• Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric or multifocal disease, no pregnant women, and no comorbid conditions precluding surgery)
• Clinical T1N0M0 invasive carcinoma or Ductal carcinoma in situ (DCIS) \< or equal to 2cm
• years of age or older or 50-59 with a low Oncotype score (0-17) Oncotype is not required for women diagnosed with DCIS.
• Estrogen receptor positive (ER+), Human epidermal growth factor 2 negative (HER2-) HER-2 status is not required for women diagnosed with DCIS.
• Women of child-bearing potential must consent to use adequate contraception during the course of the study. Female subjects must agree to use a medically acceptable contraceptives including: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD). Contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use.
• White blood cells (WBC) \> 3000, Hemoglobin ( Hgb) \> 9, platelets \>100000 within 30 days of consent
• Eligible for contrasted magnetic resonance imaging (MRI) on initial evaluation with glomerular filtration rate (GFR) ≥ 60 ml/min. A diagnostic MRI ordered within one month will be considered an acceptable alternative and will not be repeated.
• Outside breast imaging will be reviewed at Duke to confirm findings are consistent with trial eligibility.

You may not qualify if:

• Neoadjuvant chemotherapy
• Breast implant in the breast to be treated with SBRT
• Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma)
• Subjects unable to receive study treatment planning secondary to body habitus or inability to lie flat on the stomach at length
• HER2 positive
• Positive serum pregnancy test
• Insufficient breast imaging to judge clinical stage
• Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement.
• Subjects in whom treatment planning constraints cannot be met

Sponsors & Collaborators

• Duke University: lead
• Gateway for Cancer Research: collaborator

Study Sites (1)

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Clinical Trials Office
• Organization: Duke University Health System (DUHS)

RadOnc-Clinical_Trials@dm.duke.edu

919-668-3726

Study Officials

• Rachel Blitzblau, MD PhD

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: June 22, 2015
• First Posted: June 26, 2015
• Study Start: October 21, 2015
• Primary Completion: March 10, 2025
• Study Completion (Estimated): March 10, 2032
• Last Updated: March 17, 2026
• Results First Posted: March 17, 2026

Record last verified: 2026-03

Locations

US (1)