A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer
NCT06585969 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2026-02-12
Summary
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
- Metastatic Breast Cancer
- ER-positive Breast Cancer
- Luminal B
- Her2 Enriched
- Basal Like
Interventions
- DRUG
-
Trastuzumab deruxtecan (T-DXd)
Trastuzumab deruxtexan every three weeks
- DRUG
-
Ribociclib with ET
Ribociclib with endocrine therapy
- DRUG
-
Abemaciclib with ET
Abemaciclib with endocrine therapy
Sponsors & Collaborators
-
Danish Breast Cancer Cooperative Group
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-01
- Primary Completion
- 2026-01-01
- Completion
- 2026-01-01
- FDA Drug
- Yes
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