Clinical trial · Observational
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)
NCT06727227CI-TRIAL-00122426EXPLORErecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
A longitudinal, non-interventional study with trastuzumab deruxtecan for patients with HER2-low expressing unresectable or metastatic breast cancer in Bulgaria and Slovenia
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| trastuzumab deruxtecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Real-world Time to Next Treatment (rwTTNT1, median, 95% CI, measured in months)
- timeFrame
- Baseline up to 19 months
- description
- The duration from initiation of trastuzumab deruxtecan (T-DXd) treatment to the start of the subsequent therapy or death from any cause, whichever occurs first, assessed up to 19 months.
Secondary outcomes (15)
- measure
- Describe type and proportion of previous treatments for unresectable or mBC and comorbidities
- timeFrame
- Baseline
- description
- Prior treatments: surgery, chemotherapy, radiotherapy, therapies in neoadjuvant/adjuvant/advanced setting; treatment line (special focus should be given on endocrine and chemotherapy recycling in the metastatic setting). The timeline for these treatments will include all therapies administered from the time of breast cancer diagnosis.
- measure
- Duration of previous treatments and number of treatment lines
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.