A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer
Reason given: Lack of funding
Key facts
- Phase
- Phase 3
Trial details
- Who runs it
- Danish Breast Cancer Cooperative Group
- Trial code
- NCT06585969
- Record updated
- 12 February 2026
- Original description
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 cancerRead full original descriptionShow less
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
Inclusion: 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: Patients who are incapable of understanding the written material received; Other malignant disease within 5 years (in situ cervix and non-melanoma skin cancer excluded); Patients with inaccessible tumour tissue.