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Recruiting NCT06727227

Real-world Study of Trastuzumab Deruxtecan in Patients With Unresectable or Metastatic HER2-low Breast Cancer

Trial Parameters

Condition Breast Cancer
Sponsor AstraZeneca
Study Type OBSERVATIONAL
Phase N/A
Enrollment 135
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-01-29
Completion 2027-10-31
Interventions
trastuzumab deruxtecan

Brief 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.

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