Not Yet RecruitingPhase 3

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

China2,934 participantsStarted 2025-09-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Hematological: HB ≥90 g/L (no transfusion within 14 days), ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L;
✓. Biochemical: TBIL ≤1.5×ULN, ALT and AST ≤3×ULN, serum Cr ≤1×ULN, and creatinine clearance \>50 mL/min (Cockcroft-Gault formula);

What they're measuring

5-year disease-free survival in the per-protocol population

Timeframe: 5 year

Trial details

NCT IDNCT07153757

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2033-09-01

View on ClinicalTrials.gov More Breast Cancer Early Stage Breast Cancer (Stage 1-3) trials