tqb3616 capsules plus fulvestrant compared to placebo plus fulvestrant in previously treated breast cancer in clinical trail

Conditions: HR-positive,HER2-negative in Advanced Breast Cancer

Summary: this is a phase iii, a randomized, double-blind, parallel , multi-center trail to evaluate the efficacy and safety of tqb3616 capsules plus fulvestrant compared to placebo plus fulvestrant in participants with estrogen receptor-positive, her2-negative advanced breast cancer. approximately 287 women will be randomized to either tqb3616 plus fulvestrant or tqb3616-matching placebo plus fulvestrant. randomization will follow a 2:1 randomization ratio,the experimental is 191; the placebo comparator is 96.


Eligibility criteria:
inclusion criteria: * 1 the subjects voluntarily joined the study and signed the informed consent, with good compliance. * 2 age: 18-75 years old (upon signing the informed consent);ecog ps score: 0\~1; expected survival ≥3 months. * 3 participants with estrogen receptor-positive, her2-negative advanced breast cancer were identified by pathological testing. * 4 patients at the relapse/metastatic stage were allowed to receive no more than 1 line of rescue chemotherapy or rescue endocrine therapy. * 5 confirmation of at least one measurable lesion according to recist1.1 criteria. * 6 the main organs are functioning well and meet the following criteria: routine blood examination criteria (no blood transfusion or hematopoietic stimulus drug correction within 7 days before screening) : a) hemoglobin (hb) ≥100g/l; b) neutrophils absolute value (neut) ≥1.5×10\^9/l; c) platelet count (plt) ≥90×10\^9/l. biochemical tests should meet the following criteria: a) total bilirubin (tbil) ≤2.5 times the upper limit of normal (uln); b) alanine transferase (alt) and aspartate transferase (ast) ≤2.5×uln.alt and ast≤5×uln with liver metastasis. c) serum creatinine (cr) ≤1.5×uln, or creatinine clearance rate (ccr) ≥60ml/min. the blood coagulation function test should meet the following criteria: prothrombin time (pt), activated partial thromboplastin time (aptt), international standardized ratio (inr) ≤1.5×uln (no anticoagulant therapy); cardiac ultrasound evaluation: left ventricular ejection fraction (lvef)≥50%. exclusion criteria: * 1 complicated diseases and medical history: 1. has had other malignant tumors within 3 years or currently has other malignant tumors; 2. have a variety of factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction); 3. unmitigated toxicity above ctcae1 grade due to any prior treatment; 4. severe infections (≥ctcae2 grade) that were active or uncontrolled before the study treatment started; 5. cirrhosis, active hepatitis； 6. have a history of immunodeficiency, including hiv positive or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; * 2 tumor-related symptoms and treatment: 1. clinical evidence or history of central nervous system metastases (cns) and/or cancerous meningitis or pneumomeningeal disease; 2. had received chemotherapy within 3 weeks prior to the start of study treatment, and had received radiotherapy (except palliative radiotherapy for non-target lesions), hormone therapy, or other anti-tumor therapy within 2 weeks prior to the start of study treatment (washout period was calculated from the end of last treatment); 3. uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage (as determined by the investigator). * 3 known to be allergic to fluvestone, tqb3616 or any excipient. * 4 participated in clinical trials of other antitumor drugs within 4 weeks prior to the initiation of study therapy. * 5 has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.