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Can a smarter scan spot breast cancer treatment failure faster?

NCT ID NCT07130344

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study compares two types of scans—standard CT and bone scans versus PET-CT—to see which better evaluates how well the drug trastuzumab deruxtecan (T-DXd) works in people with HER2 low metastatic breast cancer. About 262 participants will be split into two groups and scanned every 3 months. The goal is to find out if PET-CT can identify non-responders earlier, potentially avoiding unnecessary side effects and costs.

What this could mean

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

Active substance
trastuzumab deruxtecan (T-DXd)
What this could lead to
If successful, this could show that PET-CT scans detect treatment response earlier than standard CT scans, helping doctors avoid ineffective treatments sooner.
What could go wrong
This is an observational imaging study, not testing a new drug. The results may not change practice if PET-CT doesn't prove clearly better than standard scans.

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 262 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Sep 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. Age greater than or equal to 18 years at inclusion 2. Cytological or histological confirmation of the diagnosis of low HER2 breast cancer (IHC 1+ or 2+ with non-amplified FISH/SIS) 3. Metastatic disease according to RECIST 1.1 4. Indication of T-DXd treatment 5. Patient (male or female of childbearing potential) using a highly effective contraceptive method 6. Women of childbearing potential must have a negative pregnancy test within 72 hours before starting treatment 7. Willingness and ability to comply with the visit schedule, treatment regimens, examinations and other procedures planned in the study 8. Patient enrolled in a health insurance plan or beneficiary of such a plan 9. Signed informed consent obtained before inclusion (after giving clear, fair and appropriate information) Exclusion Criteria: 1. Allergy to contrast dye 2. Contra-indication to PET-CT 3. Any active infection or uncontrolled intercurrent pathology 4. Patient with a life expectancy lower than 3 months 5. Ongoing participation in another clinical trial with an investigational treatment 6. Pregnant or breastfeeding women 7. Persons deprived of their freedom or under guardianship or incapable of giving consent 8. Any psychiatric illness/social situation that may limit compliance with study procedures or prevent the patient from giving written informed consent

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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

  • ICANS

    Strasbourg, 67033, France

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