Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT03909282

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

Led by Stanford University · Updated on 2026-03-12

50

Participants Needed

1

Research Sites

401 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Core needle biopsy confirming DCIS of a non-palpable, image-detected breast abnormality
  • Signed and dated IRB-approved written informed consent
  • Women aged 18 years or older
  • Mammographic calcifications or MRI non-mass enhancement measuring 4 cm or less, including multifocal disease
  • Estrogen and progesterone receptor positive or negative, HER2 status positive, negative, or unknown DCIS allowed
  • Diagnostic needle biopsy within 16 weeks before randomization
  • Presence of biopsy marker placed within tumor bed confirmed by imaging
  • Placement of Savi scout or other anatomical markers for surgery and radiation planning is preferred but not required
  • Planned lumpectomy; mastectomy allowed if lumpectomy fails or chosen after randomization
  • Radiation oncologist confirms partial breast irradiation feasibility with 30% or less breast volume in radiation field
  • Previous contralateral invasive or non-invasive breast cancer allowed
  • ECOG performance status of 0, 1, or 2
  • Concurrent atypia or lobular carcinoma in situ in either breast allowed
Not Eligible

You will not qualify if you...

  • Invasive carcinoma or microinvasive carcinoma found on core needle biopsy
  • Radiographic extent of DCIS greater than 4.0 cm
  • Presence of mass lesion on breast imaging or palpable tumor
  • No residual lesion visible on imaging after diagnostic biopsy
  • Prior history of invasive or noninvasive breast cancer in the same breast
  • Pregnant or breastfeeding
  • Prior radiation therapy to the same breast or chest area
  • Multicentric or multifocal DCIS larger than 4 cm
  • Synchronous contralateral invasive or noninvasive breast cancer
  • Paget's disease of the breast
  • Active collagen vascular disease
  • Positive axillary lymph nodes
  • Not meeting criteria for partial breast irradiation during initial evaluation
  • Psychiatric, addictive, or other disorders interfering with study participation or data interpretation
  • Use of endocrine therapy from randomization until surgery unless continued for contralateral cancer

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Stanford University

Stanford, California, United States, 94304

Actively Recruiting

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Research Team

S

Sinyoung Park

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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