Recruiting

Surgical Excision vs. Neoadjuvant Radiotherapy

Sponsor:

Stanford University

Code:

NCT03909282

Conditions

Ductal Breast Carcinoma in Situ

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lumpectomy

Partial breast irradiation prior to surgery

Study Details

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

Study ID

NCT03909282

Start date

Mar 22, 2019

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Surgical Excision

Surgical excision of ductal carcinoma

experimental: Neoadjuvant partial breast irradiation

Partial breast irradiation will be delivered once a day for 5 days before surgery. The planned daily dose is 6 Gy.

Interventions

Lumpectomy

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

Partial breast irradiation prior to surgery

Partial breast irradiation (PBI) will be delivered once aday for 5 days. The planned daily dose is 6 Gy prior to surgery (neo adjuvant)

Primary outcome measure

  • Rate of ductal carcinoma in situ (DCIS) pathologic complete response [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Sinyoung Park

650-721-4485sinyoung@stanford.edu

Locations

Stanford University

Recruiting

Stanford, California, United States, 94304

Contacts

Sinyoung Park

650-721-4485sinyoung@stanford.edu

Principal Investigator:

Irene Wapnir, MD

More Information

Sponsor

Stanford University

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Keywords

  • Ductal Breast Carcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-03-12.