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Real-world data may expand use of targeted drug for hard-to-treat breast cancer

NCT ID NCT06727227

Disease control Sponsor: AstraZeneca 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 20, 2026 · Last updated Aug 18, 2026 · Updated 3 times

Summary

This study follows 138 adults in Bulgaria and Slovenia with HER2-low advanced breast cancer who are taking trastuzumab deruxtecan (T-DXd), a targeted therapy. Researchers will track how long patients go before needing a different treatment or dying. The goal is to see how well T-DXd works in real-world settings, outside of clinical trials.

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), an antibody-drug conjugate that targets HER2-low cancer cells
What this could lead to
If successful, this study could confirm that T-DXd works well in everyday clinical practice for people with HER2-low breast cancer, supporting its broader use.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by patient selection or other factors. It does not test a new treatment, only tracks existing use.

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 138 people

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

Started

Jan 2025

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Study Population: Criteria: Age: Adult patients (≥18 years). Diagnosis: Confirmed diagnosis of unresectable or metastatic breast cancer (mBC). HER2 Status: Documented HER2-low status. Treatment Decision: Patients for whom the decision to initiate trastuzumab deruxtecan (T-DXd) treatment has been made independently and prior to enrolment in the study. Enrollment: Timing: Patients must be enrolled within 30 days before the administration of the first T-DXd infusion. Consent: Patients must provide written informed consent for data collection.

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: * Adult patient (age ≥18 years) with histological or cytological confirmed diagnosis of unresectable or mBC. * Documented HER2-low status (IHC1+, IHC2+/ISH-) in patients who have received prior chemotherapy in the metastatic setting or documented HER2-low status (IHC 1+, IHC 2+/ISH-) in patients who have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. * Recent prior decision to initiate therapy of T-DXd per SmPC (up to 30 days). Documentation confirming this decision will be required and collected. * Able and willing to provide informed consent. Exclusion Criteria: * Pregnancy or breastfeeding. * History of other primary malignancies in 2 years prior to unresectable or mBC diagnosis. * Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded. * HER2-low status patients who have previously documented HER2+ status in the same tumor.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    8 sites in 2 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Research Site

    NOT_YET_RECRUITING

    Panagyurishte, Pazardzhik, 4500, Bulgaria

  • Research Site

    RECRUITING

    Burgas, 8000, Bulgaria

  • Research Site

    NOT_YET_RECRUITING

    Plovdiv, 4004, Bulgaria

  • Research Site

    ACTIVE_NOT_RECRUITING

    Sofia, 1303, Bulgaria

  • Research Site

    ACTIVE_NOT_RECRUITING

    Sofia, 1330, Bulgaria

  • Research Site

    NOT_YET_RECRUITING

    Sofia, 1407, Bulgaria

  • Research Site

    ACTIVE_NOT_RECRUITING

    Sofia, 1431, Bulgaria

  • Research Site

    ACTIVE_NOT_RECRUITING

    Sofia, 1527, Bulgaria

  • Research Site

    NOT_YET_RECRUITING

    Sofia, 1618, Bulgaria

  • Research Site

    ACTIVE_NOT_RECRUITING

    Sofia, 1756, Bulgaria

  • Research Site

    NOT_YET_RECRUITING

    Stara Zagora, 6003, Bulgaria

  • Research Site

    ACTIVE_NOT_RECRUITING

    Varna, 9003, Bulgaria

  • Research Site

    RECRUITING

    Ljubljana, 1000, Slovenia

    Contact Email: •••••@•••••

  • Research Site

    RECRUITING

    Maribor, 2000, Slovenia

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