Preoperative Single-Fraction Radiotherapy in Early Stage Breast Cancer

Inclusion Criteria

• •1. 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.
• •2. 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)
• •3. Clinical T1N0M0 invasive carcinoma or Ductal carcinoma in situ (DCIS) \< or equal to 2cm
• •4. 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.
• •5. Estrogen receptor positive (ER+), Human epidermal growth factor 2 negative (HER2-) HER-2 status is not required for women diagnosed with DCIS.
• •6. 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.
• •7. White blood cells (WBC) \> 3000, Hemoglobin ( Hgb) \> 9, platelets \>100000 within 30 days of consent
• •8. 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.
• •9. Outside breast imaging will be reviewed at Duke to confirm findings are consistent with trial eligibility.