Status:
NOT_YET_RECRUITING
A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer
Lead Sponsor:
Danish Breast Cancer Cooperative Group
Conditions:
Metastatic Breast Cancer
ER-positive Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
Study design and setting We will conduct an international, multicentre, open-label, randomised controlled trial. All oncological departments who treat patients with metastatic breast cancer can partic...
Eligibility Criteria
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
- Patients with inaccessible tumour tissue
- Other malignant disease within 5 years (in situ cervix and non-melanoma skin cancer excluded)
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
504 Patients enrolled
Trial Details
Trial ID
NCT06585969
Start Date
May 1 2025
End Date
May 1 2029
Last Update
October 10 2024
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