drugset / Trial / NCT07153757
De-escalation Therapy in Stage I ER-Positive Breast Cancer: A Non-Inferiority Trial
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a prospective, randomized, open-label, non-inferiority Phase III clinical trial, planning to enroll 2,934 patients, with a 1:1 allocation to either the conventional endocrine therapy group or the de-escalation therapy group. The aim is to evaluate the safety and efficacy of 2-3 years of de-escalated endocrine therapy in patients with T1N0M0 potentially low-risk breast cancer, respectively.
Timeline
- Start
- 2025-09-01
- Primary completion
- 2033-09-01
- Completion
- 2033-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anastrozole | Other / unclassified | 1 mg | Oral |
| Subject | Exemestane | Small molecule | 25 mg | Oral |
| Subject | Letrozole | Other / unclassified | 2.5 mg | Oral |
| Subject | Tamoxifen | Small molecule | 10 mg | Oral |
| Subject | Toremifene | Small molecule | 60 mg | Oral |