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Observing patient outcomes in breast cancer patients treated with trastuzumab deruxtecan

Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive, HER2-low or HER2-ultralow Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan

Observational AstraZeneca · NCT05573893

This study is looking to see how well trastuzumab deruxtecan works for people with certain types of advanced breast cancer and how they feel about their treatment.

Quick facts

Study typeObservational
Enrollment800 (estimated)
Ages18 Years to 130 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionschemotherapy, trastuzumab
Locations107 sites (Amberg and 106 other locations)
Trial IDNCT05573893 on ClinicalTrials.gov

What this trial studies

This prospective non-interventional study aims to observe patient-reported outcomes and real-world clinical data in individuals with HER2-positive, HER2-low, or HER2-ultralow unresectable or metastatic breast cancer receiving trastuzumab deruxtecan (T-DXd). The study will enroll approximately 800 participants across multiple centers in Germany, with treatment and diagnostic procedures guided by the treating physician's discretion. Participants will also be informed about the use of a digital healthcare application to enhance their treatment experience.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with unresectable or metastatic breast cancer that is HER2-positive, HER2-low, or HER2-ultralow.

Not a fit: Patients with breast cancer that is resectable or those who do not meet the HER2 status criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of trastuzumab deruxtecan in real-world settings for patients with specific breast cancer subtypes.

How similar studies have performed: Other studies have shown success with similar observational approaches in understanding patient outcomes in cancer treatments.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Amberg and 106 other locations

+57 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast NeoplasmsBreast CancerNeoplasm MetastasisTrastuzumab-Deruxtecan,Human epidermal growth factor receptor 2 Positive Breast Cancer,Human epidermal growth factor receptor 2 Low Breast Cancer,Human epidermal growth factor receptor 2 Ultralow Breast Cancer,
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.