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Could Pre-Surgery radiation zap breast cancer before it spreads?

NCT ID NCT03909282

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares standard surgery alone versus a short course of radiotherapy followed by surgery for women with ductal carcinoma in situ (DCIS), a very early form of breast cancer. The goal is to see if pre-surgery radiation can completely eliminate the cancer cells in the removed tissue. Fifty women with small, non-palpable DCIS will be randomly assigned to one of the two groups, and researchers will check for any remaining cancer after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
partial breast irradiation (radiotherapy)
What this could lead to
If successful, this approach could reduce the chance of DCIS returning after surgery and may allow less extensive surgery.
What could go wrong
This is a small, early-phase pilot study with only 50 participants, so results may not apply broadly. Radiotherapy also carries risks like skin irritation or damage to nearby tissues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Stanford University

    RECRUITING

    Stanford, California, 94304, United States

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