Dalpiciclib as Adjuvant Therapy for HR-positive/HER2-negative Early-stage Patients

Inclusion Criteria

• •Female breast cancer patients aged ≥ 18 years, who are postmenopausal or premenopausal/perimenopausal;
• •Histologically confirmed HR-positive, HER2-negative early-stage breast cancer (immunohistochemical detection shows ER ≥ 10% and/or PR ≥ 10%, HER2 0-1+ or HER2 ++ but negative and non-amplified by FISH or CISH detection);
• •Histologically confirmed invasive breast cancer with postoperative pathological stage II-III;
• •Patients with or without prior neoadjuvant chemotherapy or adjuvant chemotherapy are eligible for enrollment;
• •The maximum time from surgery to enrollment does not exceed 12 months;
• •Patients receiving radiotherapy must have recovered from acute radiation reactions, with a washout period of at least 14 days from the end of radiotherapy to enrollment;
• •Patients who received previous chemotherapy must have recovered from acute adverse reactions of chemotherapy (graded ≤ 1 according to \[CTCAE\]) before enrollment, except for alopecia or grade 2 peripheral neuropathy. There must be a washout period of at least 21 days from the last chemotherapy administration to enrollment;
• •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
• •The main organ function levels must meet the following requirements: Blood routine: Neutrophil count (ANC) ≥ 1.5×10⁹/L; Platelet count (PLT) ≥ 90×10⁹/L; Hemoglobin (Hb) ≥ 90 g/L;Blood biochemistry: Total bilirubin (TBIL) ≤ 2.5×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5×ULN; Alkaline phosphatase ≤ 2.5×ULN; Blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5×ULN;
• •12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) \< 470 ms in females (QTcF calculation formula: QTcF = QT/(RR\^1/3));
• •Voluntarily participate in this study, sign the informed consent, have good compliance and are willing to cooperate with follow-up.