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Single-Dose breast radiation may cut fatigue in half

NCT ID NCT03838419

Symptom relief Sponsor: University Hospital Heidelberg 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a single dose of radiation given during breast cancer surgery (IORT) to standard whole breast radiation given over weeks. The goal is to see if IORT causes less fatigue in women with low-risk early breast cancer. About 100 women aged 50 and older with small, hormone-sensitive tumors are being enrolled.

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 could offer a shorter, less tiring radiation option for early-stage breast cancer patients.
What could go wrong
This trial is suspended, so results may never come. IORT is still experimental for this use, and long-term cancer control data are limited.

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

101 people

The number who actually took part.

Started

Oct 2019

Expected to finish

Apr 2030

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

50 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: * Histologically confirmed invasive breast cancer * Total tumor size \< 2.5 cm * cN0 * estrogen receptor positive, HER2-receptor negative on immunohistochemistry * age \>= 50 years * ECOG (Eastern Cooperative Oncology Group) Performance status ≤ 2 * Ability of subject to understand character and individual consequences of the clinical trial * Written informed consent (must be available before enrolment in the trial) Exclusion Criteria: * G3 * Extensive microcalcifications * Invasive lobular carcinoma * Clinically involved lymph nodes * No invasive axillary lymph node staging planned * Patients with significant mental or physical comorbidities that preclude regular follow-up * Neoadjuvant chemotherapy or neoadjuvant endocrine therapy * previous radiotherapy of the breast * Known carcinoma \< 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy * Pregnant or lactating women * Participation in another competing clinical study or observation period of competing trials

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • University Hospital of Heidelberg, Radiation Oncology

    Heidelberg, 69120, Germany

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