Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Investigational drug(s) / intervention(s)
Endocrine Therapy of Physician's Choice
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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
5-year disease-free survival in the per-protocol population — 5 year The proportion of patients in a clinical trial who remained free of disease recurrence, secondary primary cancers, and death from the disease for five years following treatment initiation, calculated specifically among those who completed the study intervention as predefined in the trial protocol(i.e., without major deviations such as incomplete treatment, use of prohibited therapies, or significant protocol violations).
Trial sites (1)
Facility
City
Region
Status
270 Dongan Road, Fudan University Shanghai Cancer Center
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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