Clinical trial · Observational
EUropean Real-world Experience Of Previously Treated Advanced/Metastatic HER2-positive Breast Cancer Patients Accessing Trastuzumab Deruxtecan
EUropean Real-world Experience Of Previously Treated Advanced/Metastatic HER2-positive Breast Cancer Patients Accessing Trastuzumab Deruxtecan Through a Named Patient Program (EUROPA T-DXd)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A named patient program (NPP) was initiated to allow patients with an unmet medical need to access trastuzumab deruxtecan (T-DXd) treatment. To gain early insights on the use of T-DXd outside of a trial setting, patients with advanced/metastatic HER2+ breast cancer receiving treatment (or previously treated) with T-DXd through the NPP will be invited to participate.
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 |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trastuzumab deruxtecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Trastuzumab Deruxtecan (T-DXd) Cohort
- description
- Patients with advanced/metastatic HER2-positive breast cancer who are receiving treatment (or previously treated) with trastuzumab deruxtecan (T-DXd).
- interventionNames
- Drug: Trastuzumab deruxtecan
Primary outcomes (1)
- measure
- Real-World Time-to-Treatment Discontinuation In Participants Treated With Trastuzumab Deruxtecan (T-DXd)
- timeFrame
- From the time from T-DXd initiation to the date of T-DXd discontinuation, up to 14 months
- description
- Real-world time-to-treatment discontinuation (rwTTD) is defined as the time from trastuzumab deruxtecan initiation to discontinuation for any reason in patients with advanced/metastatic HER2+ breast cancer in a real-world clinical setting.
Secondary outcomes (5)
- measure
- Type of Prior Targeted HER2-targeted Treatments In Participants Treated With Trastuzumab Deruxtecan (T-DXd)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants for whom T-DXd treatment is indicated, according to the summary of product characteristics conditionally approved by the EMA, that are eligible for treatment with T-DXd through the NPP (i.e., those with advanced/metastatic HER2+ breast cancer who have received ≥ 2 prior anti-HER2-based regimens and have documentation of HER2 positive tumour status by a validated method) will be eligible for inclusion to this RWD collection, subject to providing written informed consent to participate. Exclusion Criteria: * Any participant who does not meet all inclusion criteria noted above.
References
Publications (1)
- DERIVEDSaura C, Wildiers H, Bianchini G, Garcia-Saenz JA, Allignol A, Logue A, Lucerna M, Stamenitis S, De Laurentiis M. European experience of patients with HER2-positive advanced/metastatic breast cancer accessing trastuzumab deruxtecan through a named patient program: the EUROPA T-DXd study. Front Oncol. 2025 Oct 14;15:1650981. doi: 10.3389/fonc.2025.1650981. eCollection 2025. PMID 41164130