Status:
NOT_YET_RECRUITING
CDK4/6 Inhibitor Intensification and Chemotherapy De-Escalation for Early-stage Luminal-HER2 Breast Cancer
Lead Sponsor:
Fudan University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief Summary
The investigators designed a phase III clinical trial involving hormone receptor-positive and HER2-positive stage I breast cancer patients. This trial aims to evaluate the efficacy and safety of a tre...
Detailed Description
For patients with hormone receptor-positive and HER2-positive breast cancer, the NCCN guidelines recommend that those with tumors larger than 1 cm or positive lymph nodes should receive standard adjuv...
Eligibility Criteria
Inclusion
- Female patients aged between 18 and 75 years;
- Unilateral invasive carcinoma confirmed by histopathological examination;
- Postoperative pathological stage I early breast cancer: histologically confirmed invasive carcinoma with a maximum tumor diameter not exceeding 2 cm and no lymph node metastasis (N0);
- Estrogen receptor (ER) expression ≥ 50%;
- Immunohistochemical and molecular pathology must meet one of the following criteria: HER-2 overexpression (3+) or HER-2 (0-2+) with gene amplification confirmed by fluorescence in situ hybridization (FISH);
- Histological grade 1-2 or selected grade 3 tumors with at least one of the following additional features: PAM50 or HER2-based subtyping indicating luminal phenotype , or tumor size ≤ 1 cm );
- Adequate major organ function, defined as:
- (1) Hematologic parameters: hemoglobin (HB) ≥ 90 g/L (without blood transfusion within 14 days), absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, platelet count (PLT) ≥ 100 × 10⁹/L; (2) Biochemical parameters: total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN, serum creatinine (Cr) ≤ 1 × ULN, and calculated creatinine clearance \> 50 mL/min using the Cockcroft-Gault formula; 8) Cardiac function preserved with left ventricular ejection fraction (LVEF) \> 50%; 9) Willing to participate in the study, with signed informed consent, good compliance, and willingness to comply with follow-up requirements.
Exclusion
- Tumors with a maximum diameter exceeding 2 cm and/or presence of positive axillary lymph nodes;
- HER2-negative status defined as HER2- or HER2+ by immunohistochemistry; or HER2 2+ by immunohistochemistry without gene amplification confirmed by fluorescence in situ hybridization (FISH);
- Patients who have previously received neoadjuvant therapy or any form of systemic or non-surgical local treatment prior to enrollment, including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy;
- History of other malignant tumors, excluding cured basal cell carcinoma of the skin and cervical carcinoma in situ;
- Has metastatic (Stage 4) breast cancer;
- Pregnant or lactating women, as well as women of childbearing potential who are unable to use effective contraception;
- Patients currently enrolled in other clinical trials;
- Severe organ dysfunction involving the cardiovascular, pulmonary, hepatic, or renal systems, including left ventricular ejection fraction (LVEF) \< 50% as assessed by echocardiography; history of severe cardiovascular or cerebrovascular events within 6 months prior to enrollment (e.g., unstable angina, chronic heart failure, uncontrolled hypertension \> 150/90 mmHg, myocardial infarction, or stroke); patients with poorly controlled diabetes mellitus; patients with severe or uncontrolled hypertension;
- Active severe or uncontrolled infections;
- Patients with a history of substance abuse involving psychotropic drugs with ongoing dependency, or a documented history of psychiatric disorders that may interfere with study compliance;
- Patients deemed unsuitable for participation by the principal investigator or designated study physician.
Key Trial Info
Start Date :
October 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2035
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT07213206
Start Date
October 7 2025
End Date
September 1 2035
Last Update
October 8 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.