drugset / Trial / NCT06486883
Safety and Efficacy of T-DXd vs. CDK4/6i-based ET as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial studies a type of advanced breast cancer defined as hormone receptor HR-positive/HER2-negative and classified as non-luminal by gene expression profiling (PAM50). Patients will be treated with trastuzumab deruxtecan (T-DXd) or with physician's choice of CDK4/6 inhibitor (CDK4/6i) plus endocrine therapy (ET). The main purpose of the study is to analyze the efficacy of T-DXd in patients who have HR-positive and HER2-low/ultralow advanced breast cancer classified as non-luminal subtype.
Timeline
- Start
- 2025-06-30
- Primary completion
- 2027-01
- Completion
- 2028-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Abemaciclib | Small molecule | — | — |
| Comparator | Anastrozole | Other / unclassified | — | — |
| Comparator | Exemestane | Small molecule | — | — |
| Comparator | Fulvestrant | Small molecule | — | — |
| Comparator | Letrozole | Other / unclassified | — | — |
| Comparator | Palbociclib | Small molecule | — | — |
| Comparator | Ribociclib | Small molecule | — | — |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | 5.4 mg/kg | Intravenous |