RecruitingNCT06727227
Real-world Study of Trastuzumab Deruxtecan in Patients With Unresectable or Metastatic HER2-low Breast Cancer
REal-world Study of Trastuzumab deruXtecan in Patients With unresectabLe or Metastatic Breast Cancer Expressing HER2-lOw From BulgaRia and SlovEnia (EXPLORE)
Sponsor
AstraZeneca
Enrollment
135 participants
Start Date
Jan 29, 2025
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria4
- 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.
Interventions
DRUGtrastuzumab deruxtecan
T-DXd
Locations(14)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06727227
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