Breast cancer
Conditions
Interventions
experimental group:Chidamide combined with fulvestrant
Sponsors
Chongqing Key Laboratory of Translational Research for Cancer Metastasis and Individualized Treatment, Chongqing University Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Agree and sign a written informed consent form; 2. Postmenopausal or pre-menopausal/perimenopausal female patients aged 18 to 75 years old; meet one of the following: previous bilateral oophorectomy, or aged >= 60 years old; or aged = 50%; 10. For sufficient organ function level, the laboratory test results within 7 days before enrollment must meet the following requirements: 1) Blood routine White blood cells >=3.0x10^9/L; Neutrophils (ANC) >= 1.5x10^9/L; Platelet count (PLT) >= 90x10^9/L; Hemoglobin (Hb) >= 90g/L; 2) Blood biochemistry Total bilirubin (TBIL)<=1.5 ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)<=3 ULN; for patients with liver metastases, ALT and AST<=5 ULN; Urea nitrogen (BUN) and creatinine (Cr)<=1.5 ULN; 3) Coagulation function International normalized ratio (INR)<=1.5; activated partial prothrombin time (aPTT) or partial thrombin time (PTT)<=1.5 ULN; 11. Past endocrine can be combined with CDK4/6 inhibitor treatment for relapse or progression (OFS+tamoxifen+CDK4/6 inhibitor or AI+CDK4/6 inhibitor).
Exclusion criteria
Exclusion criteria: 1. Patients with brain metastasis or nervous system compression; 2. Primary endocrine resistance (disease progression within 2 years during adjuvant endocrine therapy or disease progression within 6 months of endocrine therapy for advanced breast cancer); 3. Patients with severe liver and kidney insufficiency; patients with severe heart insufficiency; or recent history of myocardial infarction (within 3 months); 4. There is a third space effusion that cannot be controlled by drainage or other methods (such as pleural fluid and ascites); 5. Those who have serious uncontrolled medical diseases or acute infections (the infection causes fever above 38°C); 6. Inability to swallow, intestinal obstruction or other factors that affect the taking and absorption of the drug; 7. Patients with hemorrhagic constitution, thrombocytopenia or anticoagulant therapy; 8. Those who are known to have a history of allergies to the drug components of this program; 9. Have a history of immunodeficiency, including a positive HIV test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 10. Suffered from other malignant tumors in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma; 11. Female patients during pregnancy and lactation, female patients with fertility and a positive baseline pregnancy test, or patients of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period; 12. The patient has serious concomitant diseases, or the investigator believes that the patient is not suitable for participating in any other situations in this study; 13. Have used fulvestrant and/or chidamide in the past.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Duration of relief;Disease control rate;Overall survival;safety; | — |
Countries
China
Contacts
Public ContactXiaohua Zeng; Wei Li
Chongqing Key Laboratory of Translational Research for Cancer Metastasis and Individualized Treatment, Chongqing University Cancer Hospital
Outcome results
None listed