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| ID | Type | Description | Link |
|---|---|---|---|
| BRS0096 | Other Identifier | OnCore | |
| NCI-2019-02516 | Other Identifier | National Cancer Institute: Clinical Trials Reporting Program |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Excision | Active Comparator | Surgical excision of ductal carcinoma |
|
| Neoadjuvant partial breast irradiation | Experimental | Partial breast irradiation will be delivered once a day for 5 days before surgery. The planned daily dose is 6 Gy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumpectomy | Procedure | Standard of Care surgery for DCIS (either lumpectomy or mastectomy) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sinyoung Park | Contact | 650-721-4485 | sinyoung@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Irene Wapnir, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Stanford | California | 94304 | United States |
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| ID | Term |
|---|---|
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D018270 | Carcinoma, Ductal, Breast |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D015412 | Mastectomy, Segmental |
| D008408 | Mastectomy |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Partial breast irradiation prior to surgery | Radiation | Partial breast irradiation (PBI) will be delivered once aday for 5 days. The planned daily dose is 6 Gy prior to surgery (neo adjuvant) |
|
| 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. | 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. | 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. | 12 weeks |
| Tumor cellularity comparison of radiation-induced treatment effect pathologically pre- versus post-therapy | Tumor cellularity (0-100%) will be quantified on the basis of percentage of overall residual tumor area and compared pre- and post-treatment. | 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. | 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. | 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. | 12 weeks |
| D009369 | Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D044584 | Carcinoma, Ductal |
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |