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

Not Applicable

Recruiting

• Conditions: Ductal Breast Carcinoma in Situ
• Interventions: Procedure: Lumpectomy; Radiation: Partial breast irradiation prior to surgery

• Registration Number: NCT03909282
• Lead Sponsor: Stanford University

Brief Summary

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)

Detailed Description

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 Timeline

• Study Start: 2019-03-22
• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-08
• Study First Posted: 2019-04-10
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-09
• Primary Completion: 2024-12
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neoadjuvant partial breast irradiation	Lumpectomy	Partial breast irradiation will be delivered once a day for 5 days before surgery. The planned daily dose is 6 Gy.
Surgical Excision	Lumpectomy	Surgical excision of ductal carcinoma
Neoadjuvant partial breast irradiation	Partial breast irradiation prior to surgery	Partial breast irradiation will be delivered once a day for 5 days before surgery. The planned daily dose is 6 Gy.

Primary Outcome Measures

Name	Time	Method
Rate of ductal carcinoma in situ (DCIS) pathologic complete response	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Correlation of ductal carcinoma in situ (DCIS) subtypes with rate of DCIS pathologic complete response to neoadjuvant partial breast irradiation (PBI)	12 weeks	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
Rate of invasive carcinoma comparison in Arm 1 to Arm 2	12 weeks	Rate of pathologic residual invasive carcinoma will be assessed in Arm 1 and Arm 2.
Tumor cellularity comparison of radiation-induced treatment effect pathologically pre- versus post-therapy	12 weeks	Tumor cellularity (0-100%) will be quantified on the basis of percentage of overall residual tumor area and compared pre- and post-treatment.
Correlation of post-radiation imaging characteristics with pathologic findings	12 weeks	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.
Percent tumor necrosis comparison of radiation-induced treatment effect pathologically pre- versus post-therapy	12 weeks	Percent tumor necrosis (0-100%) will be quantified on the basis of percentage of overall residual tumor area and compared pre- and post-treatment.
Proportion of subjects experiencing a wound complication on Arm 1 compared to Arm 2	12 weeks	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.
Tumor grade comparison of radiation-induced treatment effect pathologically pre- versus post-therapy	12 weeks	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	12 weeks	Degree of nuclear atypia (low, intermediate, high) will be compared pre- and post-therapy.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States