HR+, HER2- invasive breast cancer
Conditions
Interventions
Cohort 1:Dalpiciclib100mg for 2 years + aromatase inhibitor
Cohort 2:Dalpiciclib100mg for 3 years + aromatase inhibitor
Cohort 3:Dalpiciclib125mg for 2 years + aromatase inhibitor
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old, postmenopausal or premenopausal/perimenopausal patients, female patients should meet the following: a) previous bilateral oophorectomy, or age>=60 years old; b) age = 10% of all tumor cells (confirmed by the department of pathology at the study site); 2) HER2 negative was defined as 0/1+ by standard immunohistochemistry (IHC); ISH was negative (confirmed by the pathology department of the research center). 3. Patients with TNM stage T2-4,N1 or N2 or above 4. Receive radical surgery for breast cancer 5. Previous neoadjuvant therapy, including neoadjuvant chemotherapy, endocrine therapy, or CDK4/6 inhibitor therapy, was allowed 6. For subjects receiving adjuvant chemotherapy, the last dose of chemotherapy was administered no less than 21 days before randomization; For the subjects who received adjuvant radiotherapy, the interval between the last radiotherapy and the random day was not less than 14 days. 7. The Eastern Cooperative Oncology Group (ECOG) performance status was 0-1 8. Adequate organ and bone marrow function, defined as: 1) neutrophil count (ANC) >= 1500 /mm3 (1.5 × 109/L) (without G-CSF treatment within 14 days); 2) platelet count (PLT) >= 100,000/mm3 (100 × 109/L) (without corrective therapy within 7 days); 3) hemoglobin (Hb) >= 9 g/dL (90 g/L) (no corrective therapy used within 7 days) 9. Women of childbearing age must have had a negative serum pregnancy test within 28 days prior to enrollment and male/female patient willing to use a highly effective, medically approved contraceptive during the study and for 1 year after the last dose of study drug; 10. Women who are not pregnant or lactating 11. No concurrent involvement in other ongoing studies 12. Patients or their legal representatives have agreed and signed the informed consent form and are willing and able to comply with the planned visits, study treatment plan, laboratory tests, and other trial procedures.
Exclusion criteria
Exclusion criteria: 1. Her2-positive breast cancer was diagnosed by pathological examination. 2. Local or regional recurrent disease of preexisting breast malignancy. 3. Clinical stage of the tumor was stage IV (metastatic) breast cancer. 4. Bilateral breast cancer 5. History of any malignancy other than breast cancer within 5 years before randomization, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or squamous cell carcinoma. 6. History of severe pneumonia such as interstitial pneumonia. 7. Participating in clinical trials of other anti-tumor therapies (including endocrine therapy or immunotherapy) 8. Major surgical procedures, any investigational drug, or other anticancer therapy (excluding chemotherapy, radiation, or endocrine therapy for breast cancer) within 4 weeks before randomization. 9. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA >=500 IU/ml), hepatitis C (positive hepatitis C antibody and HCV-RNA above the lower detection limit of the assay), or co-infection with hepatitis B and C. 10. Within 6 months before randomization, the following occurred: Myocardial infarction, severe or unstable heartache, NYHA grade 2 or higher cardiac dysfunction, persistent arrhythmia of grade 2 or higher (according to NCI CTCAE version 5.0), atrial fibrillation of any grade, coronary/peripheral artery bypass graft surgery, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack) And symptomatic pulmonary embolism. 11. Severe infection within 4 weeks before randomization (e.g., intravenous antibiotic, antifungal, or antiviral therapy according to standard practice) or unexplained fever >38.5°C during screening or before the first dose. 12. Inability to swallow, intestinal obstruction, or other factors that interfere with drug administration and absorption. 13. Known allergy to aromatase inhibitors, LHRH agonists, dalcillib, or any excipients. 14 Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 15. Known history of psychotropic substance abuse or drug use. 16. Women within 1 year of delivery or who are breastfeeding. 17. Patients with other serious physical or mental illnesses or laboratory abnormalities that could increase the risk of participating in the study, or interfere with the results of the study, and those who were deemed by the investigators to be unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Invasive disease-free survival, iDFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival, DFS;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactLiu Chunping
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed