NCT07153757

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

A Prospective, Randomized, Open-label, Non-inferiority, Phase III Study Evaluating the Efficacy and Safety of 2 to 3 Years of Adjuvant Endocrine De-escalation Therapy for ER-positive/HER2-negative Stage I Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,934 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Interventions

Type	Name	Description
DRUG	Endocrine Therapy of Physician's Choice	This study employs a 2-3 year de-escalated endocrine therapy regimen in the experimental group, which distinguishes it from other escalation therapy studies.

Timeline

• Start date: 2025-09-01
• Primary completion: 2033-09-01
• Completion: 2033-09-01
• First posted: 2025-09-04
• Last updated: 2025-09-04

Locations

1 site across 1 country: China