CDK4/6 Inhibitor Intensification and Chemotherapy De-Escalation for Early-stage Luminal-HER2 Brea… (NCT07213206) | Clinical Trial Compass
Not Yet RecruitingPhase 3
CDK4/6 Inhibitor Intensification and Chemotherapy De-Escalation for Early-stage Luminal-HER2 Breast Cancer
1,500 participantsStarted 2025-10-07
Plain-language 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 treatment regimen combining CDK4/6 inhibitors, endocrine therapy, and anti-HER2 therapy compared with the traditional approach of chemotherapy combined with anti-HER2 therapy.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. 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:
Exclusion criteria
✕. 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;