breast cancer
Conditions
Interventions
single arm:chidamide in combination with exemestane
Sponsors
The First Affiliated Hospital of University of Science and Technology of China
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Postmenopausal adult female patients younger than 75 years old; 2. Histologically or cytologically confirmed hormone receptor positive [estrogen receptor (positive, progesterone receptor (negative or positive) breast cancer patients; 3. Disease progression or recurrence after at least one rescue endocrine drug treatment; 4. The total number of rescue endocrine therapy regimens before enrollment is = 1.5x10^9/L, platelets >= 100x10^9/L, hemoglobin 90g/L; 8. Expected survival time >= 3 months; 9. Voluntarily sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with histone deacetylase inhibitors HDACi or exemestane; 2. Past or current central nervous system metastasis, or leptomeningeal disease; 3. Simple bone metastasis; 4. Human epidermal growth factor receptor 2 (Her 2) positive; 5. Received radiotherapy within 4 weeks before enrollment; 6. No measurable lesions, such as pleural or pericardial exudate, ascites, etc.; 7. Uncontrolled or significant cardiovascular disease, including (1) Myocardial infarction occurred within 12 months before screening; (2) Uncontrolled angina pectoris occurred within 6 months before screening; (3) Congestive heart failure occurred within 6 months before screening; (4) History of any clinically significant ventricular arrhythmia such as ventricular tachycardia, ventricular fibrillation, torsades de pointes; (5) History of clinically significant QT interval prolongation, or QTc interval >450 ms during the screening period; (6) Have a history of cerebrovascular accident; (7) Symptomatic coronary heart disease requiring medical treatment. 8. Heart B-ultrasound shows that the width of the liquid dark area in the pericardial cavity at the end of diastole is >=10mm; 9. Received an organ transplant; 10. The toxicity of the original treatment regimen has not recovered before screening, and there are still toxic reactions of grade 1 or above; 11. Clinically obvious gastrointestinal abnormalities that may affect the intake, transport or absorption of drugs such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.; 12. Active infection (active bacterial, viral, fungal, mycobacterial, parasitic infection or other infection within 4 weeks before the screening period does not include nail bed fungal infection)), or requires intravenous antibiotic treatment, or targeted Antiviral therapy or hospitalization for any major infectious event], or persistent fever within 14 days prior to screening; 13. Less than 6 weeks after major organ surgery; 14. Abnormal liver function [1.5 times the upper limit of normal for total bilirubin (3 times the upper limit of normal for total bilirubin in patients with Gilbert syndrome); 2.5 times the upper limit of normal for ALT/AST in patients without liver metastases; The patient's ALT/AST is 5 times the upper limit of normal value], and the abnormal renal function is 1.5 times the upper limit of normal value of serum creatinine; 15. Currently or in the past with other malignant tumors (except for fully treated skin basal cell carcinoma or squamous cell carcinoma, carcinoma in situ of the cervix)), unless radical treatment has been performed and there is no evidence of recurrence and metastasis within the past 5 years; 16. Any mental or cognitive impairment that may limit the understanding, execution, and compliance of the informed consent form; 17. The overall survival follow-up patients who have participated in clinical trials of other drugs or are being treated in clinical trials of other drugs within 4 weeks before screening are excluded; 18. Other circumstances that the researcher considers unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Duration of Response;clinical benefit rate; | — |
Countries
China
Contacts
Public ContactPan Yueyin
The First Affiliated Hospital of University of Science and Technology of China
Outcome results
None listed