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Not yet recruiting NCT07153757

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

Phase III Interventional Breast Cancer Early Stage Breast Cancer (Stage 1-3)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endocrine Therapy of Physician's Choice.
Who it may be relevant to
Registry conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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.

Primary outcome measures

  • 5-year disease-free survival in the per-protocol population [Time frame: 5 year]
Secondary outcome measures (5)
  • 5-year disease-free survival in the Full Analysis Set [Time frame: 5 year]
  • 5-year invasive breast cancer-free survival in the per-protocol population [Time frame: 5 year]
  • Overall survival in the per-protocol population [Time frame: 5 year]
  • Quality of Life score in the per-protocol population [Time frame: 5 year]
  • safety [Time frame: 5 year]

Eligibility criteria

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:
  • 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);
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • 270 Dongan Road, Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT07153757 · SCHBCC-N097

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗