Observational study of trastuzumab deruxtecan for patients with HER2-low breast cancer

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 observational study aims to gather real-world data on the use of trastuzumab deruxtecan in patients with unresectable or metastatic HER2-low breast cancer in Bulgaria and Slovenia. It will assess various outcomes, including time to next treatment and treatment discontinuation, while also documenting patient demographics and treatment patterns prior to T-DXd therapy. The study seeks to fill the gap in real-world evidence for this treatment approach, particularly in the Balkan region, following its recent approval for HER2-low breast cancer. No formal hypothesis is set, and the study will explore multiple endpoints related to treatment effectiveness and patient management.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Burgas, Bulgaria Recruiting
• Research Site
  Ljubljana, Slovenia Recruiting
• Research Site
  Maribor, Slovenia Recruiting
• Research Site
  Panagyurishte, Pazardzhik, Bulgaria Not yet recruiting
• Research Site
  Plovdiv, Bulgaria Not yet recruiting
• Research Site
  Sofia, Bulgaria Active not recruiting

Study contacts

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

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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.