De-escalation Therapy in Stage I ER-Positive Breast Cancer: A Non-Inferiority Trial

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.

NCT Number	NCT07153757
Lead Sponsor	Fudan University
Conditions	Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Enrollment	2,934 participants
Start Date	2025-09-01
Primary Completion	2033-09-01 (estimated)
Study Completion	2033-09-01 (estimated)
Updated on ClinicalTrials.gov	2025-09-04