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)
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
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
Parallel
Lumpectomy
Procedure/SurgeryStandard of Care surgery for DCIS (either lumpectomy or mastectomy)
Partial breast irradiation prior to surgery
RadiationPartial breast irradiation (PBI) will be delivered once aday for 5 days. The planned daily dose is 6 Gy prior to surgery (neo adjuvant)
Rate of ductal carcinoma in situ (DCIS) pathologic complete response
A DCIS pathologic complete response will be defined as the absence of in situ carcinoma in the surgical resection specimen. The rate of DCIS pathologic complete response (pCR) will be calculated for Arm 1 and Arm 2.
Correlation of ductal carcinoma in situ (DCIS) subtypes with rate of DCIS pathologic complete response to neoadjuvant partial breast irradiation (PBI)
Molecular subtypes based on gene expression profiling with therapy response will be corelated. • DCIS subtypes will be defined based on grade, estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2) status as follows: * Low/intermediate grade versus high grade * ER/PR-negative versus ER/PR-positive * HER2-positive versus HER2-negative
Tumor grade comparison of radiation-induced treatment effect pathologically pre- versus post-therapy
Tumor grade (grade 1, 2, 3) will be compared pre- and post-therapy.
Nuclear atypia comparison of radiation-induced treatment effect pathologically pre- versus post-therapy
Degree of nuclear atypia (low, intermediate, high) will be compared pre- and post-therapy.
Percent tumor necrosis comparison of radiation-induced treatment effect pathologically pre- versus post-therapy
Percent tumor necrosis (0-100%) will be quantified on the basis of percentage of overall residual tumor area and compared pre- and post-treatment.
Click on the lead sponsor to view all of their trials.
