breast cancer
Conditions
Interventions
Experimental group:chidamide plus exemestane
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Eligibility
Sex/Gender
Female
Age
35 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged > 35 years, female; 2. Histologically or cytologically confirmed invasive breast cancer with ER expression > 50% and HER2 negative *; 3. TNM clinical stage was II-III (the maximum diameter of the tumor was > 2 cm); 4. Previous untreated for breast cancer; 5. At least one measurable primary lesion (by RECIST v1.1 criteria) before enrollment; 6. ECOG score 0-2 points; 7. Absolute neutrophil count >= 1.5x10^9 / L, platelets >= 100x10^9 / L, hemoglobin >= 90 g / L; 8. Voluntarily participated in this clinical trial, signed written informed consent. *HER2 negativity was defined as: (1)IHC1+/IHC0; (2)IHC2+:FISH- (HER-2/CEP17 ratio<2.0 and mean HER-2 copy number/cell < 4.0) or investigator judged HER-2 negative.
Exclusion criteria
Exclusion criteria: 1. No measurable lesion, such as pleural or pericardial effusion, ascites, etc; 2. Had undergone major surgical procedures or significant trauma within 4 weeks prior to enrollment, or anticipated that the patient would undergo major surgical treatment (non breast cancer related); 3. Previous treatment with HDAC inhibitors (including romidepsin, vorinostat, belinostat, panobinostat, entinostat, etc.); 4. Those with known history of allergy to the components of the drugs of this protocol; 5. Have a history of immunodeficiency, including a positive HIV test, or have other acquired, congenital immunodeficiency diseases, or have a history of organ transplantation; 6. Uncontrolled significant cardiovascular disease;History of clinically significant QT interval prolongation, or QTc interval > 450 ms at screening; 7. Abnormal liver function [total bilirubin > 1.5 times upper limit of normal;ALT / AST > 2.5 times the upper limit of normal], abnormal renal function (serum creatinine > 1.5 times the upper limit of normal); 8. A positive pregnancy test at baseline in a pregnant, lactating female patient or a female of childbearing potential;Or reproductive age subjects who are unwilling to take effective contraception during study participation and at least 8 weeks after the last dose; 9. Serious harms to patient safety, or concomitant diseases affecting patient completion of the study (e.g.: severe hypertension, diabetes mellitus, thyroid disease, active infection, etc.) as judged by the investigator; 10. Previous clear history of neurological or psychiatric disorders, including epilepsy or dementia; 11. Not judged by the investigator to be suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ratio of Breast cancer neoadjuvant endocrine score=0 after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete cell cycle arrest;Pathological complete remission rate; | — |
Countries
China
Contacts
Public ContactWang Xin
Tianjin Medical University Cancer Institute and Hospital
Outcome results
None listed