This study aims to evaluate the efficacy and safety of adjuvant endocrine therapy combined with dalpiciclib at different doses and durations in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast cancer.
It is a multicenter, prospective clinical study. All enrolled patients will receive either dalpiciclib 125 mg for 2 years or dalpiciclib 100 mg for 3 years, in combination with standard endocrine therapy.
The primary endpoint is 3-year invasive disease-free survival (iDFS).
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;
Stage IV breast cancer, recurrent or metastatic breast cancer, or inflammatory breast cancer;
A history of any malignant tumor, or having received anti-tumor treatment or radiotherapy for any malignant tumor in the past, excluding cured malignant tumors such as carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin;
Concurrent participation in other clinical trials;
Having received blood transfusion or treatment with colony-stimulating factors, etc. within 2 weeks before enrollment;