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. It is noted that "phase 2" is formally associated with drug studies. Nonetheless, it is however part of the time of this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Standard of Care surgery for DCIS (either lumpectomy or mastectomy)
Partial breast irradiation (PBI) will be delivered once aday for 5 days. The planned daily dose is 6 Gy prior to surgery (neo adjuvant)
Stanford University
Stanford, California, United States
RECRUITINGRate 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.
Time frame: 12 weeks
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
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
Tumor cellularity comparison of radiation-induced treatment effect pathologically pre- versus post-therapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tumor cellularity (0-100%) will be quantified on the basis of percentage of overall residual tumor area and compared pre- and post-treatment.
Time frame: 12 weeks
Proportion of subjects experiencing a wound complication on Arm 1 compared to Arm 2
Wound complications and healing will be monitored in both arms.The following events will be considered wound complications: wound dehiscence, hematoma requiring intervention, seroma requiring drainage, skin necrosis requiring resection, cellulitis requiring antibiotic therapy.
Time frame: 12 weeks
Correlation of post-radiation imaging characteristics with pathologic findings
Mammography obtained prior to surgical resection in Arm 2 patients will be assessed for the presence or absence of a residual mammographic abnormality, the size in mm of the residual mammographic abnormality and the longest span in mm of residual calcification and will be compared to the pathologic presence or absence of residual tumor, size in mm of the pathologic residual DCIS and whether the residual calcification is associated with pathologic residual DCIS.
Time frame: 12 weeks
Rate of invasive carcinoma comparison in Arm 1 to Arm 2
Rate of pathologic residual invasive carcinoma will be assessed in Arm 1 and Arm 2.
Time frame: 12 weeks