a phase i study of tqb3616 on tolerance and pharmacokinetics

Conditions: Advanced Breast Cancer

Summary: tqb3616 may work in cancer by stopping cancer cells from multiplying.tqb3616 is in a new class of drugs called cdk inhibitors.this research study is the first time that tqb3616 will be given to people.tqb3616 is taken by mouth daily.


Eligibility criteria:
inclusion criteria: 1. ≥18 years old 2. patients definitely diagnosed by pathology and/or cytology as advanced breast cancer with er+、her2-,who failed with standard endocrine therapy. 3. ecog ps:0-1,survival is expected to be greater than 3 months 4. main organs function is normal or must meet the following criteria(within past 14 days) 1) hemoglobin≥90g/l; neutrophils≥1.5 x109/l; platelets≥100 x109/l 2)albumin≥29g/l; total bilirubin ≤ 1.5 x upper limit of normal (uln); aspartic transaminase(ast) and alanine transaminase(alt)≤2.5 uln, and ≤ 5 x uln with hepatic metastasis;serum creatinine ≤1.5 xuln，creatinine clearance \>60ml/min; triglyceride≤3.0mmol/l, cholesterol≤7.75mmol/l 3)doppler ultrasound evaluation: left ventricular ejection fraction(lvef)≥50% 5.patients should be voluntary and sign the informed consent before taking part in the study exclusion criteria: 1. patients with malignant tumors, except for cured cutaneous basal cell carcinoma and cervical carcinoma in situ 2. prior treatment with chemotherapy with cytotoxic drugs within 4 weeks, mitomycin c or nirtosocarbamide within 8 weeks 3. prior treatment with any anti-cancer therapy including hormone therapy radioimmunotherapy, molecular targeted therapy, immunotherapy or other biological therapy with 2 weeks 4. patients treated with other cdk4/6 inhibitors; 5. patients with brain metastasis, spinal cord compression, cancerous meningitis, ct or mri examination reminds patients with cerebral or soft meningeal diseases in the screening phase; 6. previous history of stem cell or bowe marrow transplant; 7. a variety of factors that affect oral medication (such as inability to swallow, gastrointestinal resection, intestinal obstruction, etc.) 8. patients with non-healing wounds or fractures, except for bone metastatics with pathologic frature 9. previous history of uncontrolled cardiovascular disease including: a) grade 3 or higher congestive heart failure (nyha classification);b)unstable angina pectoris or newly developped angina pectoris within 3months before the trial; c) myocardial in farction or stroke occured within 6 months prior to intiation of trial; d) arrhythmias requiring antiarrhythmic treatment(beta-blocker or digoxin is permitted) 10. patients who need to take cyp3a4 inhibitors or inducers from the screening period; 11. patients with drug abuse history or unable to get rid of drugs or patients with mental disorders 12. patients with the urine protein≥2+, total ammount of 24 hours urinary protein determination\>1.0 grams; 13. patients with hyperactive/venous thrombosis events within 6 months,such as cerebrovascular accidents (including temporary ischemic attack), deep venous thrombosis and pulmonary embolism 14. patients with active hepatitis b or c infection 15. patients with immunodeficiency, including hiv positive or other acquired, congenital immunodeficiency disease, or organ transplant history; 16. patients allergic to tqb3616 or any adjuvant in the capsule 17. patients who took part in other trials within 4 weeks; 18. patients with concomitant diseases which could seriously endanger themselves or those who won't complete the study according to investigators;