Surgical Excision vs Neoadjuvant Radiotherapy+Delayed Surgical Excision of Ductal Carcinoma

Inclusion Criteria

   - Core needle biopsy demonstrating DCIS (ductal carcinoma in situ) of non-palpable,
   image-detected breast abnormality

   - Signed and dated IRB-approved written informed consent

   - Women 18 years of age or older

   - Mammographic calcifications or MRI non-mass enhancement measuring 4 cm or less in
   greatest dimension, including multifocal disease

   - Estrogen receptor positive or negative, progesterone receptor positive or negative
   DCIS; HER2 positive, negative or unknown DCIS is allowed.

   - Diagnostic needle biopsy within 16 weeks of randomization

   - Patients must have a biopsy marker placed within the tumor bed confirmed on post
   biopsy imaging and evidence of residual radiographic abnormality. Confirmation of
   residual imaging abnormality is required within 6 weeks of randomization.

   - Placement of Savi scout optical reflectance marker in tumor bed area as a wireless
   guide for surgery and for neoRT treatment planning is preferred but not required if
   anatomic metallic markers are sufficient for radiation planning. Placement does not
   have to occur before randomization. Additionally, wire localization before surgery is
   permissible.

   - Planned lumpectomy. Mastectomy will be acceptable if lumpectomy fails by virtue of
   involved margins or size of lesion, or patient chooses this approach after
   randomization

   - Radiation Oncologist to ascertain feasibility of PBI prior to randomization - based on
   their estimation that 30% or less of the breast volume will be encompassed in the
   radiation fields

   - Patients who had a prior contralateral invasive or non-invasive (DCIS) cancer are
   eligible

   - ECOG performance status 0, 1, or 2

   - Concurrent foci of atypia or lobular carcinoma in situ in the ipsilateral or
   contralateral breast are allowed

Exclusion Criteria

   - Invasive carcinoma on core needle biopsy, including microinvasive carcinoma

   - Radiographic extent of DCIS >4.0 cm

   - Mass lesion on breast imaging or palpable tumor

   - No residual radiographic lesion after diagnostic percutaneous core needle biopsy

   - Prior history of ipsilateral invasive or noninvasive breast cancer

   - Pregnant or breastfeeding

   - Prior ipsilateral breast or chest irradiation

   - Multicentric or multifocal DCIS, if extent is > 4cm

   - Synchronous contralateral invasive or noninvasive breast cancer

   - Pagets' disease of the breast

   - Active collagen vascular disease

   - Positive axillary lymph nodes

   - Not meeting the described criteria for partial breast irradiation during initial
   clinical evaluation.

   - Psychiatric or addictive disorders or other condition, that, in the opinion of the
   investigator, would preclude the patient from meeting the study requirements or
   interfere with the interpretation of study results

   - Endocrine therapy is not allowed from the time of study randomization to the
   completion of surgery unless the endocrine therapy is being continued for a
   contralateral cancer