Preoperative Single-Fraction Radiotherapy in Early Stage Breast Cancer
Running, not enrolling · Phase 2
Conditions studied: Breast Cancer
In brief
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
Key facts
- Study ID
- NCT02482376
- Run by
- Duke University
- People needed
- 110
- Starts
- 2015-10-21
- Expected to finish
- 2032-03-10
- Last updated by the study team
- 2026-03-17
Who can join
Age: 50 and older. Sex: female. Healthy volunteers: not accepted.
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
- 60 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
Where it is running
- Duke Cancer Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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