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Recruiting
NCT06727227
Real-world Study of Trastuzumab Deruxtecan in Patients With Unresectable or Metastatic HER2-low Breast Cancer
Conditions: Breast Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 138
Sponsor: AstraZeneca
Location: Research Site Panagyurishte Pazardzhik
Summary
A longitudinal, non-interventional study with trastuzumab deruxtecan for patients with HER2-low expressing unresectable or metastatic breast cancer in Bulgaria and Slovenia
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT06727227). StuddyBuddy aggregates publicly available trial information.