breast cancer
Conditions
Interventions
Experimental group:Regimen: oral chidamide 20mg (4 tablets) / time, 2 times a week (the interval between the two doses should not be less than 3 days, and it should be taken 30 minutes after meals)
vinorelbine 20mg/m2, intravenous infusion, d1, d8, 8 cycles
capecitabine 1000mg/m2, orally, bid, d1-14
Sponsors
ChongQing university cancer hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1). Agree and sign a written informed consent form; (2) Female and male patients = 18 years old and = 75 years old; (3). ECOG (United States Eastern Cooperative Oncology Group) score 0~1 points; (4). Expected survival of not less than 12 weeks; (5) Patients with locally advanced or metastatic breast cancer confirmed by pathology to be HER2-negative, who are not suitable for surgery or radiotherapy for the purpose of radical cure; (6). According to the criteria of RECIST1.1, at least one measurable lesion is present; (7). Patients who have received at least first-line rescue therapy (including endocrine therapy, targeted therapy, immunotherapy or chemotherapy) in the recurrent or metastatic stage; (8) Patients who relapse during neoadjuvant or adjuvant therapy (including chemotherapy, endocrine therapy, targeted therapy, etc.) or within 1 year after completion of treatment; (9). Patients who have received prior anthracycline and purple-shirt therapy (at least 2 cycles); (10). Left ventricular ejection fraction =50%; (11). Adequate functional level of organs, laboratory test results within 7 days before enrollment must meet the following requirements: 1) Complete blood count Leukocyte = 3.0×109/L; neutrophils (ANC) = 1.5×109/L; Platelet count (PLT) = 90×109/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; (12). Participants must be willing and able to comply with the protocol for the duration of the study.
Exclusion criteria
Exclusion criteria: (1). Receiving neoadjuvant or adjuvant therapy containing vinorelbine or capecitabine within half a year before the start of treatment; (2) Those who have received any HDAC inhibitors in the past; (3) Participated in other clinical trials of new drugs within 4 weeks before enrollment; (4). Patients with brain metastases or nervous system compression; (5) Patients with severe liver and kidney insufficiency; Patients with severe cardiac insufficiency; or recent history of myocardial infarction (within 3 months); (6). Presence of third space effusion (such as pleural effusion and ascites) that cannot be controlled by drainage or other methods; (7). Patients with serious uncontrolled internal diseases or acute infections (fever above 38°C caused by infection); (8). Inability to swallow, intestinal obstruction or other factors affecting drug taking and absorption; (9) Patients with hemorrhagic constitution, thrombocytopenia or anticoagulant therapy; (10). Those who are known to have a history of allergy to the drug components of this program; (11). 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; (12). Other malignant tumors within the past 5 years, excluding cured carcinoma in situ of the cervix, basal cell carcinoma of the skin or squamous cell carcinoma of the skin; (13). Pregnant and lactating female patients, female patients of childbearing potential and positive baseline pregnancy test, or patients of childbearing age who are unwilling to take effective contraceptive measures during the whole test period; (14). The patient has serious concomitant diseases, or any other condition that the investigator considers the patient to be unsuitable for participating in this study. 4.3 Exclusion criteria (1) Poor compliance, failure to accept study medication or follow-up as planned; (2). Disease progression or toxicity is intolerable; (3) Participate in clinical trials of other new drugs at the same time; (4). Radiotherapy was performed on the target lesion during the test; (5). There are other serious violations of the plan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;DOR;DCR;OS;Safety; | — |
Countries
China
Contacts
Public ContactZengXiaohua
ChongQing university cancer hospital
Outcome results
None listed