Hr-positive (ER positive, PR positive or negative) and human epidermal growth factor receptor 2 (HER-2) negative for locally advanced or metastatic breast cancer failed in endocrine therapy
Conditions
Interventions
Safety run-in:Entinote tablets combined with flavixen injection
experimental group:Entinote tablets combined with flavixen injection
control group:Flavixen injection
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients who sign informed consent form; 2. Female, age >= 18 years old and = 1% of staining cells are considered to be receptor positive); HER-2 positive means that the immunohistochemical results of pathological specimens are + + + +, or the immunohistochemical results are + + and ISH or fish positive. In the first study, the results of three types of receptors in any tumor site (i.e. primary, recurrent, or metastatic) were available. 7. Patients with at least one evaluable tumor lesion; biopsy personnel should have at least 2 measurable lesions (1 for biopsy and at least 1 for evaluation) (according to RECIST v1.1 standard); 8. Patients with disease progression or recurrence after a single endocrine drug treatment; 9. The interval between the end time of previous radiotherapy and the time of first study administration should be >= 2 weeks, and the patients must have recovered from the toxic and side effects of radiotherapy (to grade 1 or below); patients who have received radiotherapy to relieve pain outside the target lesions (such as bone metastases) or prevent pathological fractures can also be included if the acute toxicity has recovered; 10. Patients can receive drug therapy to regulate bone metabolism, such as bisphosphonates and monoclonal antibodies of RANK-L (nuclear factor kappa B ligand receptor activator), such as dinozumab; the treatment of regulating bone metabolism should be started one week before the first study administration, and the same drug must be used in the whole clinical trial except that the treatment plan needs to be modified due to the actual clinical situation; 11. Within 1 week (7 days) before the start of study administration, patients must have good organ function, which is defined as follows: Hematology: hemoglobin (Hgb) >= 90 g / L, platelet count >= 100 * 10^9 / L, absolute neutrophil count >= 1.5 * 10^9 / L. Note: before obtaining these laboratory test results, platelet transfusion is not allowed for 3 days, RBC transfusion is not allowed for 14 days, and hematopoietic growth factor (PEGylated G-CSF, erythropoietin for 14 days) is not allowed for 7 days. Renal function: serum creatinine (CRE) = 50 ml / min (Cockcroft Gault formula). Liver function: total bilirubin = 50% and QTc interval = 60 years; The serum leve
Exclusion criteria
Exclusion criteria: 1. Patients with previous or present central nervous system metastases or leptomeningeal diseases; 2. Patients with other malignant tumors (except cured basal cell carcinoma of skin or squamous cell carcinoma and carcinoma in situ of cervix), unless radical treatment has been carried out and there is no evidence of recurrence and metastasis in recent 5 years; 3. Patients with any of the following conditions within 6 months before screening: myocardial infarction, severe / unstable angina pectoris, and general terminology standard for adverse events (CTCAE) Persistent arrhythmias with v 5.0 >= 2, atrial fibrillation of any level, coronary / peripheral artery bypass grafting, NYHA grade 2 heart failure, cerebrovascular accident (including transient ischemic attack) or symptomatic pulmonary embolism; 4. Patients with pericardial effusion, pleural effusion or ascites with obvious clinical symptoms; 5. Patients with a history of immunodeficiency, including HIV positive; 6. Patients with significant clinical gastrointestinal dysfunction may affect the intake, transportation or absorption of oral drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.); 7. Patients whose toxicity caused by previous medication has not recovered or whose toxicity assessment is still higher than grade 1 of CTCAE V5.0 (except hair loss); 8. Patients who have used fluviastin or entenolate before enrollment, and other histone deacetylase (HDAC) inhibitors (such as valproic acid, vorinostat, cedabamine, etc.) before enrollment or during the study period; 9. Patients known to be allergic to fluviastin, entenole or other benzamide based drugs (such as tiberil, rimobili, clobopride, etc.) are known to be allergic to goserellin in premenopausal / perimenopausal women; 10. Patients with cognitive impairment caused by any mental or neurological disease; 11. Patients with clinically uncontrolled active infectious diseases within 2 weeks (14 days) before administration of the first study, such as acute pneumonia, active hepatitis B (HBsAg positive, and HBV-DNA copy number greater than the upper limit of the normal range), active hepatitis C (hepatitis C virus antibody positive, and HCV-RNA greater than the upper limit of the normal range), etc; 12. Patients who had undergone major surgery within 4 weeks (28 days) before administration of the first study (according to the previous medical history), had major trauma or fracture; 13. Patients who have received organ transplantation; 14. Pregnant or lactating women; 15. Patients expected to receive other anti-tumor treatment and other research drugs during the study period; 16. 4 weeks (28 days) before screening, the trial drugs that have been used in any other clinical trials or are undergoing trial drug treatment in other clinical trials (except for the patients who participated in the overall survival follow-up of a study); 17. Subjects considered unsuitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival (PFS);Rate of AEs; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Clinical benefit rate (CBR);PK; | — |
Countries
China
Contacts
Public ContactQingyuan Zhang
Cancer Hospital Affiliated to Harbin Medical University
Outcome results
None listed