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New hope for breast cancer patients who already had radiation: One-Time surgery radiation may spare mastectomy

NCT ID NCT05289466

Symptom relief Sponsor: Saint John's Cancer Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This small study tested giving a single dose of radiation directly to the tumor site during breast-conserving surgery in women with early-stage breast cancer who had already received chest radiation. The goal was to see if this approach could provide good cosmetic results and few complications, offering an alternative to mastectomy. Only 5 women were enrolled before the study was stopped early, so the findings are very limited.

What this could mean

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

Active substance
Intraoperative radiotherapy (IORT)
What this could lead to
If it works, this approach could offer a breast-conserving option for patients who previously had radiation, potentially avoiding mastectomy while maintaining good cosmetic results.
What could go wrong
This was a very small, terminated study with only 5 participants, so results are limited. The combination of prior radiation and additional IORT may increase risks of complications or poor wound healing.

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

5 people

The number who actually took part.

Started

Dec 2021

Finished

Oct 2024

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

50 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Age ≥ 50 y.o. * Histologically proven in situ and invasive ductal or lobular breast recurrence * Prior history of whole breast/chest wall radiation therapy * Disease span ≤ 3 cm, unifocal * No nodal disease (N0) * No evidence of metastatic disease (M0) * Time from initial BCT should be ≥ 1 year * Patients have refused the standard of care of mastectomy * Skin distance of ≥ 0.8 cm between applicator and skin Exclusion Criteria: * Multifocal and/or multicenter recurrence * N1-3 status: Regional cytological or histologically proven node recurrence * M1 status: Metastatic disease * cT4 (Skin or muscle involvement) or Paget's disease of the nipple * Patients undergoing mastectomy * Patients undergoing neoadjuvant systemic therapy * Connective tissue disease or scleroderma, contraindicating radiotherapy

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Conditions

The condition(s) this trial relates to.

breast cancer

As listed by the trial registrant

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

Iort-intra-operative radiation therapy

Contacts and locations

Locations

  • Providence Saint John's Hospital

    Santa Monica, California, 90404, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.