apatinib combined with cdk4/6i in first-line treatment for hr+/her2- snf4 subtype breast cancer

Conditions: Advanced Breast Cancer; HR+/HER2- Breast Cancer

Summary: this is a randomized, controlled, open-label, phase iii study to explore the efficacy and safety of apatinib in combination with standard first-line endocrine therapy for the hr+/ her2-snf4 subtype of advanced breast cancer. the study was used to explore the efficacy of apatinib in combination with standard endocrine therapy.


Eligibility criteria:
inclusion criteria: * inclusion criteria: * patients need to meet all of the following conditions * patients must be ≥18 and ≤ 75 years of age; * pathologically confirmed breast cancer is hr+/her2- breast cancer (ihc er \&gt;10%, or/and pr\&gt;10%, her 0 or +, if her2++, fish negative); * snf4 subtype definition: snf4 subtype confirmed by digital pathology of h\&e sections; * locally advanced breast cancer (radical local therapy is not possible) or metastatic breast cancer (without using adjuvant cdk4/6 inhibitors in the past, or one year after adjuvant cdk4/6 inhibitor therapy has ended); * no prior therapy (chemotherapy, targeted therapy, etc.) for advanced or metastatic breast cancer; * patients with at least one measurable lesion that has not previously received radiation therapy and can be evaluated repeatedly according to recist 1.1; * the functions of the main organs are basically normal, and the following conditions are met: 1. blood routine examination standards should meet: hb≥90g/l (no blood transfusion within 14 days); anc≥1.5×109/l; plt≥75×109/l; 2. biochemical examination shall meet the following standards: tbil≤1.5×uln (upper limit of normal value); alt and ast≤3 x uln; in case of liver metastasis, alt and ast≤5×uln; serum cr ≤1.5×uln, endogenous creatinine clearance \&gt; 50ml/min (cockcroft-gault formula); * ecog performance status 0 or 1; the expected survival is more than 3 months; * fertile female is required to use a medically approved contraceptive during study treatment and for at least 3 months after the last use of the study drug; * patients voluntarily join the study, sign the informed consent, have good compliance, and cooperate with follow-up. exclusion criteria: * patients with any of the following conditions were excluded from the study * patients with central nervous system metastasis out of control (symptoms need to use glucocorticoids or mannitol). * a history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia; * radiotherapy, chemotherapy, surgery, other targeted therapy, and immunotherapy for advanced hr+/her2- breast cancer within 4 weeks before the first administration of drugs used in this study. * pregnant or lactating patients; * other malignancies within the previous 3 years, excluding cured skin basal cell carcinoma and cervical carcinoma in situ; * significant comorbid medical conditions, including mental illnesses that the investigator or sponsor believes would adversely affect the patient\&#39;s participation in the study; * allergic physique, or known allergic history of the drug components of this program; or allergic to other monoclonal antibodies; * the investigator does not consider the patient suitable for participation in any other circumstances of the study.

Keywords: hr+/her2- breast cancer advanced breast cancer