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One and done? new study tests single-dose radiation boost for breast cancer

NCT ID NCT07590505

Disease control Sponsor: Cancer Research Antwerp 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Updated 2 times

Summary

This completed phase 3 trial tested whether a single, high-dose radiation boost (6 Gy in one session) is as good as the standard 5-session boost (10 Gy total) after whole-breast radiation in 132 breast cancer patients who had breast-conserving surgery. The main goal was to see if cosmetic outcomes were similar, while also checking side effects like breast pain and fibrosis, and quality of life. If successful, this could reduce treatment burden for patients.

What this could mean

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

Active substance
Radiation therapy (ultrahypofractionated sequential boost)
What this could lead to
If it works, this could shorten radiation treatment for breast cancer patients from 5 extra sessions to just 1, while maintaining similar cosmetic results and quality of life.
What could go wrong
This is a single-center trial with only 132 participants, so results may not apply to all patients. The experimental single-dose boost might cause more side effects like breast pain or fibrosis, and it may not be as effective as the standard approach.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

132 people

The number who actually took part.

Started

Mar 2022

Finished

Mar 2026

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: * Breast cancer patients referred for WBRT + boost to the lumpectomy cavity * Patients ≥18y * Karnofsky Performance Score \>70%, or ECOG \<2 * Life expectancy of more than 5 years * Invasive tumour free resection margins, defined as R0 resection on the pathology report * Written informed consent Exclusion Criteria: * Previous contralateral breast cancer * Previous RT of the same breast or thorax. * Metastatic disease (M1)

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm neoplasm

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • Ziekenhuis aan de stroom

    Antwerp, Antwerpen, 2610, Belgium

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