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New study tracks Real-World effects of breast cancer drug in 800 patients

NCT ID NCT05573893

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 4 times

Summary

This study is observing about 800 adults with advanced breast cancer (HER2-positive, low, or ultralow) who are receiving the drug trastuzumab deruxtecan as part of their normal care in Germany. Researchers are tracking how long patients stay on the drug before switching treatments and how their quality of life changes. The goal is to gather real-world data on the drug's effectiveness and safety outside of a controlled trial.

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 800 people

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

Started

Sep 2023

Expected to finish

Dec 2031

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

Patients with documented Human epidermal growth factor receptor 2 (HER2)-positive, HER2-low or HER2-ultralow unresectable or metastatic breast cancer (BC) receiving T-DXd in line with the applicable summary of product characteristics (SmPC) within routine clinical practice may participate in this NIS.

Ages

18 to 130 years

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. Adults ≥ 18 years old 2. Patients (irrespective of sex and gender) with pathologically documented breast cancer that: * is unresectable or metastatic * has confirmed HER2+, HER2-low or HER2-ultralow tumor status by local pathology * was previously treated with one or more anti-HER2 directed therapy if the tumor is HER2+ OR * was previously treated with at least one endocrine therapy in the metastatic setting and is not considered suitable for endocrine therapy as the next line of treatment if the tumor is HR+, HER2-low or HER2-ultralow OR * was previously treated with prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy if the tumor is HER2-low. 3. Has documented radiologic progression (during or after most recent treatment) 4. Patient is eligible for T-DXd treatment in line with the specifications mentioned in the ENHERTU® SmPC and is scheduled for T-DXd treatment \* 5. Patient is able to read and understand either German or English 6. Signed written informed consent * The prescription of the medicinal product is clearly separated from the decision to include the patient in this NIS. Exclusion Criteria: 1. Start of T-DXd treatment for more than 30 days before enrolment (eCRF registration date) 2. Known hypersensitivity to T-DXd or any of the excipients of the drug 3. Pregnancy or breast feeding 4. Current or planned participation in an interventional clinical trial 5. Current or planned systemic treatment of any tumor other than unresectable or metastatic BC Patients who have never received any T-DXd dose will be discontinued from the study and will be considered as a late screening failure, no further documentation besides reason and date of discontinuation is needed.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm HER2 positive breast carcinoma metastatic neoplasm Neoplasm Metastasis

As listed by the trial registrant

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

Breast cancer Breast neoplasms Neoplasm metastasis

How to take part

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

  1. The places running it

    105 sites. 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

  • Research Site

    WITHDRAWN

    Amberg, 92224, Germany

  • Research Site

    WITHDRAWN

    Ansbach, 91522, Germany

  • Research Site

    RECRUITING

    Apolda, 99510, Germany

  • Research Site

    RECRUITING

    Aschaffenburg, 63739, Germany

  • Research Site

    RECRUITING

    Augsburg, 86150, Germany

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    Augsburg, 86156, Germany

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    Bad Reichenhall, 83435, Germany

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    Baden-Baden, 76532, Germany

  • Research Site

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    Balingen, 72336, Germany

  • Research Site

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    Bamberg, 96049, Germany

  • Research Site

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    Berlin, 10117, Germany

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    RECRUITING

    Berlin, 10367, Germany

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    RECRUITING

    Berlin, 10715, Germany

  • Research Site

    RECRUITING

    Berlin, 12623, Germany

  • Research Site

    RECRUITING

    Berlin, 13125, Germany

  • Research Site

    RECRUITING

    Bielefeld, 33604, Germany

  • Research Site

    RECRUITING

    Bonn, 53111, Germany

  • Research Site

    RECRUITING

    Brandenburg an der Havel, 14770, Germany

  • Research Site

    RECRUITING

    Braunschweig, 38100, Germany

  • Research Site

    RECRUITING

    Bremen, 28209, Germany

  • Research Site

    RECRUITING

    Bremerhaven, 27574, Germany

  • Research Site

    RECRUITING

    Coburg, 96450, Germany

  • Research Site

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    Dessau, 6847, Germany

  • Research Site

    RECRUITING

    Donauwörth, 86609, Germany

  • Research Site

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    Dortmund, 44137, Germany

  • Research Site

    RECRUITING

    Dresden, 1127, Germany

  • Research Site

    RECRUITING

    Dresden, 1307, Germany

  • Research Site

    RECRUITING

    Düsseldorf, 40235, Germany

  • Research Site

    RECRUITING

    Eggenfelden, 84307, Germany

  • Research Site

    WITHDRAWN

    Erfurt, 99085, Germany

  • Research Site

    RECRUITING

    Essen, 45147, Germany

  • Research Site

    RECRUITING

    Filderstadt - Bonlanden, 70794, Germany

  • Research Site

    RECRUITING

    Frankfurt, 60389, Germany

  • Research Site

    RECRUITING

    Freudenstadt, 72250, Germany

  • Research Site

    RECRUITING

    Fürstenfeldbruck, 82256, Germany

  • Research Site

    RECRUITING

    Fürstenwalde, 15517, Germany

  • Research Site

    RECRUITING

    Gerlingen, 70839, Germany

  • Research Site

    RECRUITING

    Giessen, 35392, Germany

  • Research Site

    RECRUITING

    Halle, 6110, Germany

  • Research Site

    RECRUITING

    Hamburg, 20259, Germany

  • Research Site

    RECRUITING

    Hamburg, 21073, Germany

  • Research Site

    RECRUITING

    Hanover, 30161, Germany

  • Research Site

    RECRUITING

    Hanover, 30449, Germany

  • Research Site

    RECRUITING

    Hansestadt Salzwedel, 29410, Germany

  • Research Site

    RECRUITING

    Heidenheim, 89522, Germany

  • Research Site

    RECRUITING

    Heilbronn, 74078, Germany

  • Research Site

    RECRUITING

    Hildesheim, 31134, Germany

  • Research Site

    RECRUITING

    Homburg/Saar, 66421, Germany

  • Research Site

    RECRUITING

    Jena, 7747, Germany

  • Research Site

    RECRUITING

    Kaiserslautern, 67655, Germany

  • Research Site

    RECRUITING

    Karlsruhe, 76135, Germany

  • Research Site

    RECRUITING

    Kassel, 34117, Germany

  • Research Site

    RECRUITING

    Kassel, 34125, Germany

  • Research Site

    RECRUITING

    Kempten, 87439, Germany

  • Research Site

    RECRUITING

    Kiel, 24116, Germany

  • Research Site

    RECRUITING

    Krefeld, 47805, Germany

  • Research Site

    RECRUITING

    Kulmbach, 95326, Germany

  • Research Site

    RECRUITING

    Landshut, 84036, Germany

  • Research Site

    RECRUITING

    Leer, 26789, Germany

  • Research Site

    RECRUITING

    Leipzig, 4103, Germany

  • Research Site

    RECRUITING

    Loerrach, 79539, Germany

  • Research Site

    RECRUITING

    Lübeck, 23562, Germany

  • Research Site

    RECRUITING

    Lüneburg, 21339, Germany

  • Research Site

    RECRUITING

    Magdeburg, 39130, Germany

  • Research Site

    RECRUITING

    Mainz, 55131, Germany

  • Research Site

    RECRUITING

    Marburg, 35037, Germany

  • Research Site

    RECRUITING

    Memmingen, 87700, Germany

  • Research Site

    RECRUITING

    Mönchengladbach, 41061, Germany

  • Research Site

    RECRUITING

    Mutlangen, 73557, Germany

  • Research Site

    RECRUITING

    Mühlhausen, 99974, Germany

  • Research Site

    RECRUITING

    München, 80638, Germany

  • Research Site

    RECRUITING

    München, 80639, Germany

  • Research Site

    RECRUITING

    München, 81377, Germany

  • Research Site

    WITHDRAWN

    Neumarkt, 92318, Germany

  • Research Site

    RECRUITING

    Neuruppin, 16816, Germany

  • Research Site

    RECRUITING

    Neustadt am Rübenberge, 31535, Germany

  • Research Site

    RECRUITING

    Nordhausen, 99734, Germany

  • Research Site

    RECRUITING

    Nuremberg, 90419, Germany

  • Research Site

    RECRUITING

    Oldenburg, 26121, Germany

  • Research Site

    RECRUITING

    Oranienburg, 16515, Germany

  • Research Site

    RECRUITING

    Potsdam, 14467, Germany

  • Research Site

    RECRUITING

    Recklinghausen, 45659, Germany

  • Research Site

    RECRUITING

    Regensburg, 93053, Germany

  • Research Site

    RECRUITING

    Rosenheim, 83022, Germany

  • Research Site

    RECRUITING

    Rotenburg (Wümme), 27356, Germany

  • Research Site

    RECRUITING

    Saalfeld, 7318, Germany

  • Research Site

    RECRUITING

    Saarbrücken, 66113, Germany

  • Research Site

    RECRUITING

    Schwäbisch Hall, 74523, Germany

  • Research Site

    RECRUITING

    Siegen, 57072, Germany

  • Research Site

    RECRUITING

    Singen, 78224, Germany

  • Research Site

    RECRUITING

    Solingen, 42653, Germany

  • Research Site

    RECRUITING

    Stade, 21680, Germany

  • Research Site

    RECRUITING

    Stuttgart, 70199, Germany

  • Research Site

    RECRUITING

    Torgau, 4860, Germany

  • Research Site

    RECRUITING

    Troisdorf, 53840, Germany

  • Research Site

    RECRUITING

    Ulm, 89073, Germany

  • Research Site

    RECRUITING

    Ulm, 89075, Germany

  • Research Site

    RECRUITING

    Walsrode, 29664, Germany

  • Research Site

    RECRUITING

    Weiden, 92637, Germany

  • Research Site

    RECRUITING

    Weinheim, 69469, Germany

  • Research Site

    RECRUITING

    Wessenfels, 6667, Germany

  • Research Site

    RECRUITING

    Westerstede, 26655, Germany

  • Research Site

    RECRUITING

    Wiesbaden, 65199, Germany

  • Research Site

    RECRUITING

    Winnenden, 71364, Germany

  • Research Site

    RECRUITING

    Witten, 58452, Germany

  • Research Site

    RECRUITING

    Wolfsburg, 38440, Germany

  • Research Site

    RECRUITING

    Wuppertal, 42283, Germany

  • Research Site

    RECRUITING

    Würzburg, 97080, Germany

  • Research Site

    RECRUITING

    Zittau, 02763, Germany

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