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

RecruitingN/A

Sponsor: AstraZeneca

Conditions: Breast Cancer

Interventions: trastuzumab deruxtecan

Countries: Bulgaria, Slovenia

A longitudinal, non-interventional study with trastuzumab deruxtecan for patients with HER2-low expressing unresectable or metastatic breast cancer in Bulgaria and Slovenia

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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.

Locations (14)

Panagyurishte, Pazardzhik, Bulgaria
Burgas, Bulgaria
Plovdiv, Bulgaria
Sofia, Bulgaria
Sofia, Bulgaria
Sofia, Bulgaria
Sofia, Bulgaria
Sofia, Bulgaria
Sofia, Bulgaria
Sofia, Bulgaria
Stara Zagora, Bulgaria
Varna, Bulgaria
Ljubljana, Slovenia
Maribor, Slovenia