Status:
NOT_YET_RECRUITING
De-escalation Therapy in Stage I ER-Positive Breast Cancer: A Non-Inferiority Trial
Lead Sponsor:
Fudan University
Conditions:
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 gro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2033
Estimated Enrollment :
2934 Patients enrolled
Trial Details
Trial ID
NCT07153757
Start Date
September 1 2025
End Date
September 1 2033
Last Update
September 4 2025
Active Locations (1)
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1
270 Dongan Road, Fudan University Shanghai Cancer Center
Shanghai, China, 200032