Real-world Study of Trastuzumab Deruxtecan in Patients With Unresectable or Metastatic HER2-low Breast Cancer
Recruiting now
Conditions studied: Breast Cancer
In brief
A longitudinal, non-interventional study with trastuzumab deruxtecan for patients with HER2-low expressing unresectable or metastatic breast cancer in Bulgaria and Slovenia
Key facts
- Study ID
- NCT06727227
- Run by
- AstraZeneca
- People needed
- 138
- Starts
- 2025-01-29
- Expected to finish
- 2027-10-31
- Last updated by the study team
- 2026-07-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Research Site — Burgas, Bulgaria (enrolling)
- Research Site — Ljubljana, Slovenia (enrolling)
- Research Site — Maribor, Slovenia (enrolling)
- Research Site — Sofia, Bulgaria
- Research Site — Sofia, Bulgaria
- Research Site — Sofia, Bulgaria
- Research Site — Panagyurishte, Pazardzhik, Bulgaria
- Research Site — Sofia, Bulgaria
- Research Site — Sofia, Bulgaria
- Research Site — Stara Zagora, Bulgaria
- Research Site — Varna, Bulgaria
- Research Site — Sofia, Bulgaria
- Research Site — Plovdiv, Bulgaria
- Research Site — Sofia, Bulgaria
Full record on ClinicalTrials.gov
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