Postmenopausal hormone receptor positive and EGFR negative, advanced breast cancer
Conditions
Interventions
Single drug group:Oral administration of BEBT-209 drugs
Combination group:Oral administration of letrozole tablets and BEBT-209 drugs
Sponsors
Xiangya Hospital Central South University
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18 to 65 years; 2. In postmenopausal women with ER + / her2-breast cancer, there is evidence of local recurrence or metastasis, which is not suitable for surgical resection or radiotherapy for the purpose of cure. Postmenopausal women: (1) Patients who had previously undergone bilateral oophorectomy; (2) The postmenopausal state confirmed by medicine is defined as the spontaneous cessation of menstruation for at least 12 consecutive months without other pathological or physiological reasons; (3) Subjects aged >=60 years. 3. Previous treatment: (1) Stage I B single drug group: previous failure of anti estrogen treatment and at least one chemotherapy regimen. (2) Stage I B combined medication group: it is required that no systemic anti-cancer treatment for local recurrence or metastatic ER + breast cancer has been received before. 4. Patients with measurable lesions defined in RECIST v.1.1, or with only osteolytic bone metastases (judged by the investigator based on clinical manifestations). Patients who have received radiotherapy or other local treatment in the past are only regarded as measurable lesions if there is clear record of disease progression at the treatment site after treatment; 5. ECoG score is 0-1. 6. Patients with sufficient organ and bone marrow function are defined as follows: ANC >=1500 / mm (1.5 x 10^9/L); platelets >=100,000/mm (100 x 10^9/L); hemoglobin >=9 g/dl (90 g/L); ALT or AST =60 ml / min (according to Cockcroft and Gault formula); 7. Those patients whose acute toxicity of previous anticancer treatment or surgery has been reduced to baseline severity or ncictcae version 5.0 <=1 (except for alopecia or other toxicity that the researchers believe is not safe for the patients); 8. Those who are willing to sign informed consent after comprehensive understanding.
Exclusion criteria
Exclusion criteria: 1. Patients with any other malignant tumor (except for fully treated basal cell or squamous cell skin cancer or cervical carcinoma in situ); 2. Symptomatic, disseminated to the viscera, and risk of life-threatening complications in a short period of time (patients with visceral crisis); inflammatory breast cancer; 3. Patients with known or symptomatic active CNS metastasis show clinical symptoms, brain edema, spinal cord compression, cancerous meningitis, leptomeningeal disease and / or progressive growth; 4. Patients who have undergone major surgery, chemotherapy, radiotherapy, any investigational drug or other anti-cancer treatment within 4 weeks before the first administration; 5. Patients who received the following treatment within 7 days before entering the study: drugs known as CYP3A4 strong inhibitor / inducer; drugs known to significantly prolong QT interval; 6. QTc interval > 480 msec (based on the average value of three screening ECG [ECGs]); patients with long QT syndrome history or long QT syndrome family history confirmed; patients with clinically significant ventricular arrhythmia history, or currently using antiarrhythmic drugs or implanting defibrillation device for the treatment of ventricular arrhythmia; 7. Uncontrollable electrolyte disorder may affect the effect of QTc drugs (such as hypocalcemia =2, atrial fibrillation of any level, coronary / peripheral artery bypass, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism); 9. Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome or patients who have undergone any upper gastrointestinal surgery including gastrectomy; known to have malabsorption syndrome or other conditions that may impair the absorption of bebt-209; 10. Patients with allergic history or suspected allergic symptoms to any component of letrozole and bebt-209 capsules; 11. Patients with the following clinically significant active infections, including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related diseases. Active hepatitis B is defined as: HBsAg or HBeAg positive, and HBV DNA >=2000 IU/ml (equivalent to 104 copies/ml); active hepatitis C is defined as HCV RNA higher than the detection limit; 12. Patients with other severe acute or chronic medical or psychiatric disorders or laboratory abnormalities may increase the risk of participating in the study or the risk associated with the administration of the study drug, or interfere with the results of the study, as well as other situations in which the investigator believes that the patients are not suitable to participate in the study; 13. Patients with recent or active suicidal thoughts or behaviors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;Safety and tolerance;RP2D; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;PFS;CBR; | — |
Countries
China
Contacts
Public ContactQian Changgeng
Guangzhou BeBetter Medicine Technology Co.,LTD
Outcome results
None listed