Clinical trial · Interventional
A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer
NCT06585969CI-TRIAL-00103120DISCORDANTwithdrawnPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of funding
Summary
Brief summary (as posted)
The objective of this trial, DBCG R25, will be to evaluate the effect of trastuzumab-deruxtecan versus standard of care on progression-free survival (PFS) in first-line for patients with non-Luminal A, ER-positive/HER2-negative metastatic breast cancer
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Like | — | UNRESOLVED | — |
| ER-positive Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Her2 Enriched | — | UNRESOLVED | — |
| Luminal B | Luminal B Breast Carcinoma | ALIAS | 0.90 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abemaciclib with ET | Drug | — | UNRESOLVED |
| Ribociclib with ET | Drug | — | UNRESOLVED |
| Trastuzumab deruxtecan (T-DXd) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Trastuzumab-deruxtecan
- description
- Trastuzumab deruxtecan until progression or intolerable toxicity: 5.4 mg/kg intravenous on day 1 of a 21 days cycle.
- interventionNames
- Drug: Trastuzumab deruxtecan (T-DXd)
- type
- ACTIVE_COMPARATOR
- label
- Immunohistochemistry guided treatment (standard)
- description
- \- CDK4/6 inhibitor with an endocrine therapy until progression og intolerable toxicity * CDK4/6 inhibitor: Physician's choice of ribociclib (600mg daily for 21 days in a 4 week schedule) or abemaciclib (125mg twice daily). * Endocrine therapy: letrozole (2.5mg daily), anastrozole (1mg daily), exemestane (25mg daily), tamoxifen (20mg daily) or fulvestrant (intramuscular 500mg every 4 weeks)
- interventionNames
- Drug: Ribociclib with ET
- Drug: Abemaciclib with ET
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 18 or above. * Radiologically/pathologically verified metastatic breast cancer. * ER-positive (1% or more) and HER2-low (HER2 1+ or HER2 2+/ISH-neg)10,11. * PAM50 Luminal B, HER2-enriched or Basal-like. * Performance status 0-1. * Evaluable disease Exclusion Criteria: * Patients who are incapable of understanding the written material received * Patients with inaccessible tumour tissue * Other malignant disease within 5 years (in situ cervix and non-melanoma skin cancer excluded)
References
Publications (0)
Data not yet available
No reference posted for this study.