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One-Shot radiation before second breast surgery: a new hope for recurrence?

NCT ID NCT06640881

Disease control Sponsor: Amsterdam UMC, location VUmc Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 17, 2026 · Updated 3 times

Summary

This study tests whether a single, high dose of radiation given before repeat breast-conserving surgery is safe and effective for women whose breast cancer has returned after previous treatment. The trial will enroll 25 women aged 50 or older with small, low-risk tumors. The goal is to reduce side effects and improve cosmetic results compared to standard post-surgery radiation.

What this could mean

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

Active substance
single-dose partial breast irradiation (radiation therapy)
What this could lead to
If successful, this approach could offer a less toxic, more cosmetic-friendly option for women with recurrent breast cancer, potentially reducing the need for mastectomy.
What could go wrong
This is a small, early-phase trial with only 25 participants, so results may not apply to all patients. The main risk is radiation-related side effects, and it is not yet known if this approach controls cancer as well as standard treatments.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 25 people

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

Started

Jan 2025

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

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: * WHO performance scale ≤ 2 * Females at least 50 years of age with an ipsilateral invasive breast cancer event or DCIS (i.e. recurrence, second primary) after previous breast conserving surgery and radiotherapy (for invasive breast cancer/carcinoma in situ) * Tumor characteristics: - - Tumor size ≤ 2 cm, unifocal on MRI On tumor biopsy: * Bloom-Richardson grade 1 or 2, * non-lobular invasive histological type carcinoma, * accompanying (non-extensive) DCIS is accepted within the tumor size of 2 cm on mammography and/or tumor biopsy, including no non-mass enhancement on MRI, * ER-positive and HER2-negative tumor, * No lymphovascular invasion. * Clinical node negative on PET-CT, ultrasound and MRI * No distant metastases * Repeat breast-conserving surgery is feasible, if no or mild late toxicity (no grade 2 or higher) from previous breast-conserving therapy * Adequate communication and understanding skills of the Dutch language * Written informed consent Exclusion criteria: * Ipsilateral invasive breast cancer recurrence less than 2 years after first breast conserving therapy for breast cancer or ductal carcinoma in situ * Legal incapacity * Known breast cancer mutation gene carrier * Previous ipsilateral mastectomy * Collagen synthesis disease (e.g. Osteogeneis imperfecta, Ehlers-Danlos syndrome, systemic lupus erythematosus) * Invasive lobular carcinoma * MRI absolute contraindications as defined by the Department of Radiology * Indication for treatment with neoadjuvant chemotherapy * Non-feasible dosimetric RT plan * Breast implants

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Conditions

The condition(s) this trial relates to.

breast carcinoma breast neoplasm

As listed by the trial registrant

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

Ipsilateral recurrence Recurrent breast carcinoma

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

  • Amsterdam UMC / VU Medical Centre

    RECRUITING

    Amsterdam, Netherlands

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