This study is a multicenter, prospective, randomized, open-label clinical study to assess the efficacy and safety of endocrine combined with different doses and treatment duration of darisenatide adjuvant therapy in HR +/HER2- early breast cancer. The study planned to include 2000 HR +/HER2- early breast cancer patients who met the study criteria and were randomized in a 1:1 ratio to Column 1 and Column 2 stratified by nodal status (positive/negative), prior (neo) adjuvant chemotherapy (yes/no), and clinical/pathological stage (Stage II/III).
Cohort 1 received dalcili 125 mg in combination with endocrine therapy for 2 years with dalcili; Cohort 2 received dalcili 100 mg in combination with endocrine therapy for 3 years with dalcili; treatment had to be discontinued until disease progression, intolerable adverse events, withdrawal of consent, or investigator judgment.
Female aged 18 years or older with breast cancer who are postmenopausal or premenopausal/perimenopausal.
Patients with early-stage breast cancer whose HR status is positive and HER2 status is negative, as confirmed by histology (immunohistochemistry showing ER ≥10% and/or PR ≥10%, HER2 0-1+ or HER2 ++ but negative by FISH or CISH testing, with no amplification).
Patients with histologically confirmed invasive breast cancer at clinical/pathological stages II-III.
Patients who have previously received or not received neoadjuvant chemotherapy or adjuvant chemotherapy are eligible to enroll.
Stage IV breast cancer or recurrent/metastatic breast cancer, or inflammatory breast cancer;
A history of any malignant tumor, or previous receipt of anti-tumor therapy or radiotherapy for any malignant tumor, excluding cured cases of cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma, etc.
Participating in other clinical trials simultaneously;
Received a blood transfusion within 2 weeks prior to enrollment, or received treatments such as colony-stimulating factors;
Parallel
Dalpiciclib 125mg
DrugDalpiciclib: 125 mg, once daily, taken at approximately the same time every day, fasting 1 hour before and after taking the drug, for 21 consecutive days, followed by 7 days off, 28 days as a treatment cycle. It was administered for 2 years.
Dalpiciclib 100mg
DrugDalpiciclib: 100 mg, once daily, taken at approximately the same time every day, fasting 1 hour before and after taking the drug, for 21 consecutive days, followed by 7 days off, 28 days as a treatment cycle. It was administered for 3 years.
Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen
DrugEndocrine therapy: endocrine therapy drugs selected by the investigator, including aromatase inhibitors (AIs), fulvestrant, tamoxifen, toremifene, etc.
3-year invasive disease-free survival
Defined as the time from the date of enrollment until the first occurrence of one of the following iDFS events: invasive ipsilateral or contralateral recurrent breast cancer, local or regional recurrence, distant metastasis, and death from any cause.
Distant Disease- Free Survival
From the date of enrollment until the first distant relapse or death from any cause.
overall survival
Time from enrollment to death from any cause.
Patient Reported Outcomes
Collected by EORCT QLQ-C30 Quality of Life Scale
Safety Results
Record adverse events (AEs) and serious adverse events (SAEs) separately in accordance with the NCI CTC AEv5.0 criteria.
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