Real-world Study of Trastuzumab Deruxtecan in Patients With Unresectable or Metastatic HER2-low Breast Cancer
Recruiting · NCT06727227 · Observational (researchers observe without assigning treatment) · Lead sponsor: AstraZeneca
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
A longitudinal, non-interventional study with trastuzumab deruxtecan for patients with HER2-low expressing unresectable or metastatic breast cancer in Bulgaria and Slovenia
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
14 locations listed.
- Research Site - Burgas, Bulgaria
- Research Site - Ljubljana, Slovenia
- Research Site - Maribor, Slovenia
- Research Site - Plovdiv, Bulgaria
- Research Site - Sofia, Bulgaria
- Research Site - Sofia, Bulgaria
- Research Site - Sofia, Bulgaria
- Research Site - Sofia, Bulgaria
- Research Site - Sofia, Bulgaria
- Research Site - Sofia, Bulgaria
- Research Site - Sofia, Bulgaria
- Research Site - Stara Zagora, Bulgaria
- Research Site - Varna, Bulgaria
- Research Site - Panagyurishte, Pazardzhik, Bulgaria