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

RECRUITINGSponsored by AstraZeneca
Actively Recruiting
SponsorAstraZeneca
Started2025-01-29
Est. completion2027-10-31
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions2

Breast CancerCancer

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