middle-high risk HR+ early stage breast cancer
Conditions
Interventions
Queue 1:Dalpiciclib 125mg combined with endocrine therapy in which Dalpiciclib was treated for 2 years
Queue 2:Dalpiciclib 125mg combined with endocrine therapy in which Dalpiciclib was treated for 3 years
Sponsors
Jilin Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Postmenopausal or premenopausal/perimenopausal female breast cancer patients aged >=18 years; 2. Histologically confirmed HR-positive HER2-negative breast cancer (ER >=10% and/or PR >=10% by immunohistochemistry, HER2 0-1 + or HER2 ++ but negative by FISH or CISH, no amplification); 3. For histologically confirmed invasive breast cancer, the postoperative pathological stage is IIA-IIIC stage, of which stage IIA includes N1 or N0 with: Grade2 combined with risk factor Ki-67 >=20% or Grade3. 4. Patients with or without prior neoadjuvant chemotherapy or adjuvant chemotherapy could be enrolled; 5. No more than 12 months from operation to enrollment; 6. Patients receiving radiotherapy must recover from the acute phase of radiotherapy with a washout period of at least 14 days from the end of radiotherapy to enrolling; 7. Patients who had previously received chemotherapy must have recovered from acute adverse effects of chemotherapy ([CTCAE] grade =1.5×10^9/L; Platelet count (PLT) >=90×10^9/L; Hemoglobin (Hb) >=90 g/L; b) Blood biochemistry: total bilirubin (TBIL)<=2.5×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=1.5×ULN Alkaline phosphatase <=2.5×ULN; Urea nitrogen (BUN) and creatinine (Cr) <=1.5×ULN; c) 12-lead electrocardiogram: Fridericia corrected QT interval (QTcF) female < 470 ms (QTcF formula QTcF=QT/(RR^1/3)); 10. Voluntarily participate in this study, sign informed consent, have good compliance and be willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Stage IV breast cancer or recurrent metastatic breast cancer or inflammatory breast cancer; 2. Have had any malignancy in the past or have received anti-tumor therapy or radiotherapy for any malignancy in the past, excluding malignant tumors such as cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma that have been cured; 3. Participate in other clinical trials; 4. Blood transfusion or treatment with colony-stimulating factors within 2 weeks before enrollment; 5. Known allergic history of the drug components of this protocol; 6. A history of immunodeficiency, including HIV testing positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation. 7. Have had any heart disease, including: (1) angina; (2) medically treatable or clinically significant arrhythmias; (3) myocardial infarction; (4) Heart failure; (5) Any other heart disease that is judged by the investigator to be unsuitable for participation in the study. 8. Pregnant and lactating female patients; 9. Any other circumstances in which the investigator considers the subject inappropriate for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Invasive Disease- Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Distant Disease- Free Survival;overall survival;Adverse event;Patient-Reported Outcomes; | — |
Countries
China
Contacts
Public ContactGuiying Xu
Jilin Cancer Hospital
Outcome results
None listed