A Prospective, Single-Arm Clinical Study on the Treatment of HR+/HER2- Breast Cancer With Neoadjuvant Chemotherapy Combined With Anlotinib and Benmelstobart Monoclonal Antibody
Our center plans to conduct a prospective, single-arm exploratory clinical study to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with Anlotinib and Benmelstobart in the treatment of HR+/HER2- breast cancer. The aim is to further explore the treatment strategy of chemotherapy de-escalation for patients with HR+/HER2- breast cancer, provide more treatment options for breast cancer patients, and offer a potential theoretical basis for the precision treatment of breast cancer.The primary study objective is to evaluate the pathologic complete response(PCR)and RCB0-1 ratio of neodjuvant treatment of HR+/HER2- breast cancer.
• Female patients aged between 18 and 75 years old.
• With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
• Patients with histologically or pathologically confirmed invasive ductal carcinoma of the breast, and simultaneously meeting the following conditions:
• T1c (≥1 cm) - 4c N0-2; Histologically confirmed as grade 3 by the research center; Immunohistochemical staining results confirm ER+ (≥1%), HER2 negative (Her2/neu fluorescence in situ hybridization (FISH) ratio ≤ 1.8 or IHC 0 or 1+); and the combined positive score (CPS) is greater than or equal to 10 points. The PD-L1 antibody site detected in our center is 22C3.
• Have not received any previous treatment.
• The functional levels of the major organs must meet the following requirements (no blood transfusion, and no use of drugs for increasing white blood cells or platelets within 2 weeks before screening):
‣ Blood routine: Absolute neutrophil count (ANC) \> 1.5×10⁹/L; platelet count (PLT) \> 75× 10⁹/L; hemoglobin (Hb) \> 90 g/L; lymphocyte count ≥ 1.5×10⁹/L.
⁃ Blood biochemistry: Total bilirubin (TBIL) \< 1.5× the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 1.5×ULN; alkaline phosphatase \< 2.5×ULN; blood urea nitrogen/urea (BUN/UREA) and creatinine (Cr) \< 1.5×ULN.
⁃ Echocardiogram: Left ventricular ejection fraction (LVEF) \> 55%.
⁃ 12-lead electrocardiogram: The corrected QT interval using the Fridericia method (QTcF) \< 470 msec.
• For premenopausal female patients or those who have not undergone surgical sterilization: Use an effective contraceptive method during the treatment period and for at least 6 months after the last administration of the study treatment.
• Voluntarily participate in this study, sign the informed consent form, have good compliance, and be willing to cooperate with the follow-up.