Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Fudan University
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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;
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.
You may not be if
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.
Clareo Health | De-escalation Therapy in Stage I ER-Positive Breast Cancer: A Non-Inferiority Trial
