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

NCT03909282 | Recruiting DMC FDA Device

• 3 other identifiers: IRB-46373BRS0096NCI-2019-02516
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Conditions

Ductal Breast Carcinoma in Situ

Keywords

Ductal Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Correlation of ductal carcinoma in situ (DCIS) subtypes with rate of DCIS pathologic complete response to neoadjuvant partial breast irradiation (PBI)

  12 weeks

• Tumor grade comparison of radiation-induced treatment effect pathologically pre- versus post-therapy

  12 weeks

• Nuclear atypia comparison of radiation-induced treatment effect pathologically pre- versus post-therapy

  12 weeks

• Percent tumor necrosis comparison of radiation-induced treatment effect pathologically pre- versus post-therapy

  12 weeks

• Tumor cellularity comparison of radiation-induced treatment effect pathologically pre- versus post-therapy

  12 weeks

Study Arms (2)

Surgical Excision

ACTIVE COMPARATOR

Surgical excision of ductal carcinoma

Procedure: Lumpectomy

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.

Procedure: Lumpectomy; Radiation: Partial breast irradiation prior to surgery

Interventions

Lumpectomy PROCEDURE

Standard of Care surgery for DCIS (either lumpectomy or mastectomy)

Also known as: Mastectomy

Neoadjuvant partial breast irradiation; Surgical Excision

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)

Neoadjuvant partial breast irradiation

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Estrogen receptor positive or negative, progesterone receptor positive, negative or unknown; HER2 positive, negative or unknown DCIS is allowed
• Diagnostic needle biopsy within 16 weeks of randomization
• Patients must have a biopsy marker placed within the tumor bed confirmed on post biopsy imaging.
• Placement of Savi scout optical reflectance marker in tumor bed area as a wireless guide for surgery and for neoRT treatment planning is preferred but not required if anatomic metallic markers are sufficient for radiation planning. Placement does not have to occur before randomization. Additionally, wire localization before surgery is permissible.
• Planned lumpectomy. Mastectomy will be acceptable if lumpectomy fails by virtue of involved margins or size of lesion, or patient chooses this approach after randomization
• Radiation Oncologist to ascertain feasibility of PBI prior to randomization - based on their estimation that 30% or less of the breast volume will be encompassed in the radiation fields
• Patients who had a prior contralateral invasive or non-invasive (DCIS) cancer are eligible
• ECOG performance status 0, 1, or 2
• Concurrent foci of atypia or lobular carcinoma in situ in the ipsilateral or contralateral breast are allowed

You may not qualify if:

• 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
• Prior history of ipsilateral invasive or noninvasive breast cancer
• Pregnant or breastfeeding
• Prior ipsilateral breast or chest irradiation
• Multicentric or multifocal DCIS, if extent is \> 4cm
• Synchronous contralateral invasive or noninvasive breast cancer
• Pagets' disease of the breast
• Active collagen vascular disease
• Positive axillary lymph nodes
• Not meeting the described criteria for partial breast irradiation during initial clinical evaluation.
• Psychiatric or addictive disorders or other condition, that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with the interpretation of study results
• Endocrine therapy is not allowed from the time of study randomization to the completion of surgery unless the endocrine therapy is being continued for a contralateral cancer

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Ductal, Breast

Interventions

Mastectomy, Segmental; Mastectomy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma, Ductal; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Irene Wapnir, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sinyoung Park

CONTACT

650-721-4485; sinyoung@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 10, 2019
• Study Start: March 22, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)