Advanced breast cancer
Conditions
Interventions
Experimental group:Culmerciclib plus endocrine therapy
Control group:mono-chemotherapy
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily participated in this study and signed the informed consent form, showing good compliance; 2. Age: 18 - 75 years old (at the time of signing the informed consent form); ECOG PS score: 0 - 2; Expected survival period: more than 3 months; 3. Post-menopausal or pre-menopausal/peri-menopausal female patients, meeting any of the following criteria: (1) Have undergone bilateral oophorectomy in the past; (2) Age >= 60 years old; (3) Age 3 lesions; (2) At least 2 visceral sites involved; (3) Symptomatic ascites or pleural effusion, defined as requiring weekly drainage and accompanied by measurable visceral metastatic lesions; 7. Subjects must have adequate bone marrow and organ function, tested by local laboratories and meeting the following standards: a. Absolute neutrophil count >= 1.5 × 10^9/L b. Platelets >= 100 × 10^9/L c. Hemoglobin >= 9.0 g/dL d. Estimated glomerular filtration rate calculated by Cockcroft-Gault formula >= 30 mL/min. e. Total bilirubin < ULN; Patients with Gilbert syndrome can be included, but must meet any of the following conditions: total bilirubin <= 3.0 × ULN, or direct bilirubin <= 1.5 × ULN, or patients with liver metastasis have total bilirubin <= 1.5 × ULN; f. AST < 2.5 × ULN, for patients with liver metastasis, AST < 5 × ULN; ALT < 2.5 × ULN, for patients with liver metastasis, ALT < 5 × ULN. 8. Patients considered by the investigator to have indications for single-agent chemotherapy. 9. Allowed to receive <= 1 line of chemotherapy or ADC drugs in the advanced stage. 10. Allowed to enroll subjects who have received CDK4/6i treatment in the adjuvant stage but have relapsed or progressed after completing the adjuvant CDK4/6i treatment. Note: The recurrence or progression of previous treatment must be confirmed by imaging examination; 11. Pregnant women of childbearing age should agree to use contraception measures (such as intrauterine device, contraceptive pills or condoms) during the study period and for 6 months after the study; the serum pregnancy test should be negative within 7 days before the study enrollment, and must be non-lactating s
Exclusion criteria
Exclusion criteria: 1. Previously diagnosed as HER2-positive breast cancer by pathological examination; 2. Patients who are contraindicated for treatment with cumoselim; 3. Patients with primary resistance to endocrine therapy, that is, recurrence within 2 years of adjuvant endocrine therapy, or disease progression within 6 months of advanced first-line endocrine therapy; 4. Patients who have received more than 2 lines of endocrine therapy previously; 5. Patients who have received CDK4/6 inhibitor treatment in the advanced stage; 6. Patients with sole bone metastasis; 7. Patients with human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS), active hepatitis B (HBV DNA >= 1000IU/ml), hepatitis C (positive hepatitis C antibody, and HCV-RNA higher than the detection limit of the analytical method) or co-infection with both hepatitis B and hepatitis C; 8. Patients who experienced >= 2 grade myocardial ischemia, myocardial infarction, congestive heart failure (New York Heart Association (NYHA) classification), need for treatment of arrhythmia (including screening period QTc >= 480ms), and uncontrolled hypertension within 6 months before the start of the study treatment; as well as fever > 38.5? without control during the screening period or before the first administration; 9. Patients with severe infection within 4 weeks before the first administration (such as requiring intravenous infusion of antibiotics, antifungal or antiviral drugs according to clinical diagnosis and treatment guidelines), or unexplained fever > 38.5? during the screening period or before the first administration; 10. Patients unable to swallow, intestinal obstruction or having other factors affecting drug administration and absorption; 11. Patients with known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 12. Patients with known history of drug abuse or drug use in the form of drugs; 13. Pregnant or lactating women; 14. Any other circumstances that the investigator deems the subject is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical benefit rate;Overall survival period;The time until treatment failure; | — |
Countries
China
Contacts
Public ContactQingyuan Zhang
Harbin Medical University Cancer Hospital
Outcome results
None listed