Observing patient outcomes in breast cancer patients treated with trastuzumab deruxtecan

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Research Site
  Apolda, Germany Recruiting
• Research Site
  Aschaffenburg, Germany Recruiting
• Research Site
  Augsburg, Germany Recruiting
• Research Site
  Augsburg, Germany Recruiting
• Research Site
  Bad Reichenhall, Germany Recruiting
• Research Site
  Baden-Baden, Germany Recruiting

+59 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Brain metastases from breast cancer: see how trastuzumab deruxtecan in CSF relates to effect

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• Trastuzumab Deruxtecan plus ivonescimab for HR+ HER2-low advanced breast cancer

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• Pyrotinib and Trastuzumab with Dalpiciclib vs with Docetaxel in advanced HER2-positive breast cancer

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• Tucatinib with trastuzumab and capecitabine for HER2‑positive metastatic breast cancer in routine care

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.