Phase II Surgical Excision vs Neoadjuvant Radiotherapy+Delayed Surgical Excision of Ductal Carcinoma
Phase II Surgical Excision vs Neoadjuvant Radiotherapy+Delayed Surgical Excision of Ductal Carcinoma
The purpose of this pilot study is to compare by pathological findings surgical excision
 versus neoadjuvant radiotherapy followed by delayed surgical excision of ductal carcinoma in
 situ (DCIS)
There will be measurable histopathological treatment effects identified in Arm 2 cases
 receiving pre-operative radiation Results found are expected to assist in designing a more
 definitive study. Compare pathological findings in individuals with ductal carcinoma in situ
 (DCIS) who have surgical excision versus neoadjuvant radiotherapy followed by delayed
 surgical excision
Inclusion Criteria:

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

 -  Mammographic or MRI non-mass lesion (calcifications, non-mass enhancement on MRI)
 measuring 3 cm or less in greatest dimension

 -  Estrogen receptor positive or negative, progesterone receptor positive or negative;
 HER2 positive or negative DCIS

 -  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. The post-biopsy
 mammogram must be performed within 6 weeks of randomization date

 -  Placement of Savi scout optical reflectance marker for contouring of tumor bed area
 for partial breast irradiation treatment planning via mammography, CT, or MRI and for
 image-guiding of surgery

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

 -  Evaluation by Radiation Oncologist to ascertain feasibility of PBI prior to
 randomization. Planned breast irradiation should encompass less than 30% of the breast
 volume

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

 -  Eastern cooperative oncology group (ECOG) performance status 0, 1, or 2

 Exclusion Criteria:

 -  Invasive carcinoma on core needle biopsy, including microinvasive carcinoma

 -  Radiographic extent of DCIS >3.0 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

 -  Synchronous contralateral invasive or non-invasive breast cancer

 -  Pagets' disease of the breast

 -  Active collagen vascular disease

 -  Positive axillary lymph nodes

 -  Not meeting the described dosimetric criteria for partial breast irradiation during
 radiation planning

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

 -  Endocrine therapy is not allowed prior to surgery unless continued for a contralateral
 cancer