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NCT07153757

PHASE3

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2934

Start Date

2025-09-01

Completion Date

2033-09-01

Last Updated

2025-09-04

Healthy Volunteers

Conditions

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

Interventions

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.

Inclusion Criteria: * Females aged 18 years or older; * Postoperative pathological stage I early breast cancer: histologically confirmed invasive carcinoma with a maximum diameter ≤2 cm and node-negative (N0); * Immunohistochemistry (IHC) shows ER-positive (ER ≥50%), HER2 IHC score of 0, 1+, or 2+ with no amplification confirmed by FISH, and Ki-67 ≤20%; * Presence of at least one of the following potential low-risk factors: 1）Tumor size ≤1 cm, 2）21-gene recurrence score \<11, 3）Fudan digital pathological subtype classified as SNF1, 4）Age ≥65 years; * ECOG performance status of 0 or 1; * Patients with bilateral synchronous invasive lesions are eligible if both lesions are ER-positive, HER2-negative, and meet the tumor size criteria; * Normal major organ function, meeting the following criteria: 1. Hematological: HB ≥90 g/L (no transfusion within 14 days), ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L; 2. Biochemical: TBIL ≤1.5×ULN, ALT and AST ≤3×ULN, serum Cr ≤1×ULN, and creatinine clearance \>50 mL/min (Cockcroft-Gault formula); * Participants voluntarily enroll, sign informed consent, demonstrate good compliance, and cooperate with follow-up. Exclusion Criteria: * Primary tumor size \>2 cm in maximum diameter and/or axillary lymph node positivity; * Prior neoadjuvant therapy, any systemic therapy, or local therapy (except surgery), including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy; * Prior adjuvant chemotherapy; * Use of CDK4/6 inhibitors in the adjuvant setting; * History of other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ); * Metastasis at any site; * Pregnancy, lactation, or women of childbearing potential unable to use effective contraception; * Concurrent participation in other clinical trials; * Severe cardiac, pulmonary, hepatic, or renal dysfunction; LVEF \<50% (by echocardiography); severe cardio-cerebrovascular diseases within 6 months (e.g., unstable angina, chronic heart failure, uncontrolled hypertension \>150/90 mmHg, myocardial infarction, or stroke); poorly controlled diabetes; severe hypertension; * Severe or uncontrolled infections; * History of drug abuse or psychiatric disorders; * Patients deemed unsuitable for the study by the investigator.

Locations (1)

270 Dongan Road, Fudan University Shanghai Cancer Center

Shanghai, China