untreated hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer
Conditions
Interventions
maintenance of CDK4/6 inhibitors:None
Sponsors
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Shenzhen
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Recurrent metastatic breast cancer confirmed by pathology or dynamic imaging; 2. Confirmed HR positive and HER2 negative by pathological test; 3. No treatment has been carried out for the treatment of recurrent and metastatic lesions; 4. The function of vital organs meets the following requirements (no blood transfusion, no use of hematopoietic stimulating factors, and no use of drugs to correct blood cell count) within 14 days prior to the first dose: neutrophil Cell count 1.5x10^9/L, hemoglobin concentration 90g/L, platelet count 100x10^9/L; ALT and AST <3.0 x ULN; TBIL<1.5 x ULN; Cr<1.5 x ULN; 5. Expected survival greater than 3 months; 6. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Prior adjuvant therapy: prior treatment with CDK4/6 inhibitors; 2. Concomitant medical diseases that are not eligible for chemotherapy; 3. Pregnant and lactating patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Adverse events; | — |
Countries
China
Contacts
Public ContactXuelian Chen
Shenzhen Hospital, Cancer Hospital of Chinese Academy of Medical Sciences
Outcome results
None listed