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New study aims to spot hidden cancer spread in lobular breast cancer

NCT ID NCT07635654

Knowledge-focused Sponsor: KU Leuven 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study will test whether whole-body MRI scans and blood tests for tumor DNA can better detect cancer progression in a type of breast cancer that is often missed by standard scans. Researchers will follow 43 people with metastatic invasive lobular carcinoma for up to 30 months, comparing the new methods with usual care. The goal is to see if these tools help doctors make better treatment decisions and improve patient access to trials.

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 could lead to better monitoring of metastatic lobular breast cancer, helping doctors detect progression earlier and allowing more patients to qualify for clinical trials.
What could go wrong
This is a small, early-stage observational study (43 people) that is not yet recruiting. It tests imaging and blood tests, not a treatment, so it will not directly improve outcomes. Results may not apply to all patients.

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

About 43 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jun 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

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: 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures 2. At least 18 years of age at the time of signing the Informed Consent Form (ICF) 3. ECOG from 0 to 2 4. Patient with stage IV ILC, either de novo or after prior (curative) treatment for early ILC. Histological subtype confirmed on primary tumor or on metastatic tissue. Patients that are diagnosed with stage IV breast cancer that have a mixed ILC/IBC-NST histology of the primary tumor (mixed histology within the same primary lesion) will also be able to participate and will be analyzed in an exploratory cohort. 5. Confirmation of hormone receptor positive (HR+)/HER2- disease either on new biopsy or archival tissue (e.g. primary tumor) 6. Multifocal or bilateral disease is allowed if all evaluated foci present with HR+/HER2- ILC 7. Starting first line of treatment for metastatic ILC Exclusion Criteria: 1. Presence of a contraindication to perform WB-DWI/MRI 2. Presence of severe claustrophobia 3. Presence of a contraindication to use IV contrast for CT or PET/CT (e.g. allergy, severe renal failure) in case a non-contrast PET/CT cannot be performed 4. Patients considered to have oligometastatic disease who are expected to undergo locoregional treatment 5. Presence of other malignancies in recent medical history (\<5 years) 6. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive 7. Adults who are the subject of a legal protection measure or who are unable to express their consent.

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Conditions

The condition(s) this trial relates to.

Carcinoma, Lobular invasive lobular breast carcinoma

As listed by the trial registrant

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

Invasive lobular breast carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. 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 ↗

  2. 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.

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