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New study tracks best way to treat recurrent breast cancer with radiation and heat

NCT ID NCT06452485

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 17, 2026 · Updated 3 times

Summary

This study follows 500 breast cancer patients whose cancer has returned in the same area (locoregional recurrence). They receive standard care: re-irradiation with or without hyperthermia (heat therapy). The goal is to track side effects, quality of life, and survival over five years using patient questionnaires. The data will help design a future randomized trial to compare these treatments more directly.

What this could mean

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

What this could lead to
If successful, this study could provide real-world data to help doctors and patients make better decisions about re-irradiation and hyperthermia for recurrent breast cancer.
What could go wrong
This is an observational study, not a treatment trial, so it will not directly test whether one approach is better. Results depend on patient reports and may not apply to all cases.

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.

Participants

About 500 people

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

Started

Feb 2024

Expected to finish

Oct 2027

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.

Who is studied

Eligible patients with local and/or regional recurrence (LRR), i.e true recurrence or second primary tumor: 1. After previous breast-conserving therapy and LRR with high-risk characteristics\* treated with salvage mastectomy after previous mastectomy or salvage mastectomy and postoperative re-irradiation +/- hyperthermia treatment. In both groups (neo)-adjuvant treatment 2. After previous mastectomy with a chest wall recurrence treated with local excision with or without NAST and postoperative re irradiation (+/-hyperthermia). If these patients have a complete clinical/radiological response after NAST and no surgery (i.e. local excision) is performed, treatment with re-irradiation (with/without hyperthermia) is indicated. Treatment with regional re-irradiation in case of a regional recurrence after (targeted) axillary dissection is allowed.

Ages

18 years and older

Sex

Anyone

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: * ≥ 18 years old * WHO performance scale ≤ 2 * Diagnosed with local +/- regional recurrence (LRR) (i.e. true recurrence or second primary) with high-risk tumor characteristics\* and previously treated with postoperative local +/- regional irradiation for primary breast cancer/previous recurrence with an indication for salvage mastectomy with/without postoperative re-irradiation (+/-hyperthermia)\*\* if re-irradiation: including overlap of re-irradiated volume with previous irradiated volume * Diagnosed with a chest wall recurrence and treated with local excision with/without NAST and postoperative re irradiation with/without hyperthermia. In patients with a clinical/radiological complete response after neoadjuvant systemic treatment, NO surgery and re irradiation (+/- hyperthermia) (since surgery is not possible in this group) * (Neo-)adjuvant systemic (NAST) treatment is allowed * Use of PET(FES/FDG)-CT for staging of nodal and disseminated disease * Oligometastases in lymph nodes in the mediastinum, neck, contralateral axillary/supraclavicular region (up to a maximal number of five) is allowed * Proficient in Dutch at a level allowing to understand the questionnaires and patient information sheet \* Definition of high-risk tumor characteristics are: * (Focal) irradical resection * All clinical and pathological stages except for low-risk LRR: - rcT1-2N0 - r(y)pT1-2N0 \*\* according to local clinical practice and/or shared decision making process Exclusion criteria: • Diagnosed with primary breast sarcoma

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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

  • Amsterdam UMC

    RECRUITING

    Amsterdam, Netherlands

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