Breast cancer
Conditions
Interventions
Experimental group:Chidamide+pharmorubicin +cyclophosphamide+docetaxel neoadjuvant therapy
Sponsors
Shengjing Hospital of China Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 18-75 years; 2. All patients were histopathologically confirmed to be estrogen receptor (ER) positive (> 10%) and HER2 negative, following the 2018 ASCO-CAP HER2 Negative interpretation Guidelines; 3. Newly treated patients with stage II-III tumor stage meeting AJCC version 8 criteria; 4. KPS score >= 70; 5. The functional level of the organ must meet the following requirements: (1) Bone marrow function 1) ANC >= 1.5×10^9/L (growth factor not used within 14 days); 2) PLT >= 100×10^9/L (no corrective treatment within 7 days); 3) Hb >= 100 g/L (no corrective treatment within 7 days); (2) Liver and kidney function 1) TBIL 1.5xULN or less; 2) ALT and AST = 50mL/min (Cockcroft-Gault formula); 6. Able to receive needle biopsy; 7. Voluntarily participated in the study, signed informed consent, had good compliance and was willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Have previously received any other form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.); 2. Receiving any other antitumor therapy; 3. Bilateral breast cancer, inflammatory breast cancer or ocessive breast cancer; 4. Stage IV breast cancer; 5. Breast cancer without histopathological diagnosis; 6. Other malignant tumors within the past 5 years, except cured carcinoma in situ of the cervix; 7. Severe heart, liver, kidney and other important organ dysfunction; 8. Inability to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug taking and absorption; 9. Participated in clinical trials of other drugs within 4 weeks before enrollment; 10. Known history of allergy to the drug components of this regimen; History of immunodeficiency, including HIV positive, HCV, active hepatitis B or other acquired or congenital immune deficiency diseases, or a history of organ transplantation; 11. History of any heart disease, including :(1) medically required or clinically significant arrhythmia; (2) myocardium infarction; (3) heart failure; (4) any other heart disease deemed unsuitable for the study by the investigator; 12. Pregnant, lactating women, fertile women with positive baseline pregnancy test or in the entire women of reproductive age who were unwilling to use effective contraception during the trial; 13. Concomitant diseases (including but not limited to severe hypertension that cannot be controlled by drugs, severe diabetes, active infection, etc.) that seriously endanger patient safety or affect the completion of the study, as determined by the investigator; 14. A clear past history of neurological or psychiatric disorders, including epilepsy or dementia. 15. The investigator concluded that the patient was not suitable for the study any other circumstances.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Residual cancer burden 0-1 points ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;Breast pathological complete response rate;Objective remission rate;Breast-conserving rate; | — |
Countries
China
Contacts
Public ContactCaigang Liu
Shengjing Hospital of China Medical University
Outcome results
None listed