Breast cancer
Conditions
Interventions
A group:TQB3616 Capsules with an aromatization inhibitor (letrozole)
B group:TQB3616 Capsules with an aromatization inhibitor (anastrozole)
Sponsors
Liaoning Cancer Hospital & Institute
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily join this study, sign the informed consent form, and have good compliance; 2. Age: 18-75 years old (at the time of signing the informed consent form); ECOG PS score: 0~1 points; Expected survival of more than 3 months; 3. Postmenopausal or premenopausal/perimenopausal female patients who meet any of the following: (1) Previous bilateral oophorectomy; (2) Age>=60 years; (3) Age =12 months (without chemotherapy, triphenoxyamine, toremifene, or ovarian castration drugs in the past 1 year), follicle-stimulating hormone (FSH) and estradiol (E2) levels in the postmenopausal range; (4) Premenopausal or perimenopausal patients may also be enrolled, but must be willing to receive LHRH agonist therapy during the study. 4. Patients with HR-positive and HER2-negative breast cancer confirmed by pathological examination, with evidence of local lesion recurrence or distant metastasis, who are not suitable for surgery or radiotherapy with curative intent, and have no clinical indications for chemotherapy: (1) HR positivity includes estrogen receptor ER positive and/or progesterone receptor PR positive, defined as: the proportion of positive stained tumor cells to all tumor cells >=10% (confirmed by the pathology department of the study center); (2) HER2 negative: standard immunohistochemistry (IHC) test is 0/1; If the test shows 2, in situ hybridization [ISH] must be performed to confirm that it is negative or ISH only to be negative (confirmed by the pathology department of the site site). 5. Subjects enrolled in Cohort 1 must meet any of the following requirements: (1) Relapse or progression during adjuvant endocrine therapy or within 1 year after completion of adjuvant endocrine therapy, and no subsequent treatment (aromatase inhibitors cannot be used in adjuvant endocrine therapy); (2) Relapse or progression more than 1 year after completion of adjuvant endocrine therapy, and re-progression after receiving advanced endocrine therapy; or disease progression after advanced endocrine therapy for primary metastatic disease (aromatase inhibitors cannot be used on advanced endocrine therapy). For recurrent/metastatic disease, no more than 1 line of salvage chemotherapy and no more than 1 line of advanced endocrine therapy are allowed, but the end-line regimen must be endocrine therapy; 6. Completion of adjuvant endocrine therapy in Cohort 1 defined as discontinuation after at least 2 years of continuous treatment; 7. Cohort 2 enrolled subjects must meet the requirements of no previous systemic anti-tumor therapy for local lesion recurrence or metastatic disease; 8. According to RECIST 1.1 criteria, there must be at least one measurable lesion confirmed; 9. Major organ functions should be satisfactory and meet the following criteria: (1) Hematology standards (no blood transfusion or use of hematopoietic stimulating agents for correction within 7 days before screening): 1) Hemoglobin (HB) >= 100 g/L; 2) Absolute neutrophil count (NEUT) >= 1.5×10^9/L; 3) Platelet count (PLT) >= 90 ×10^9/L. (2) Biochemical examination criteria: 1) Total bilirubin (TBIL) = 60 ml/min. (3) Coagulation function criteria: 1) Prothrombin time (PT), activated partial
Exclusion criteria
Exclusion criteria: 1. Previous pathological examination diagnosed HER2-positive breast cancer; 2. Bilateral breast cancer or inflammatory breast cancer; 3. Comorbidities and medical history: (1) Other malignant tumors occurring within 3 years or currently occurring simultaneously. The following two situations are eligible: other malignant tumors treated with a single surgery, achieving 5 consecutive years of disease-free survival (DFS); cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)]; (2) Multiple factors affecting oral and drug absorption (such as difficulty swallowing, post-gastrointestinal resection, ulcerative colitis, symptomatic/inflammatory bowel disease, chronic diarrhea, and intestinal obstruction); (3) History of serious pneumonia such as interstitial lung disease; (4) Unresolved toxicity reactions higher than CTC AE grade 1 caused by any previous treatments, excluding alopecia; (5) Major surgery or significant traumatic injury within 28 days prior to the start of study treatment; (6) Long-term non-healing wounds or fractures; (7) Occurrence of arterial/venous thromboembolic events within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; (8) History of psychiatric drug abuse that cannot be discontinued or the presence of psychiatric disorders; (9) Subjects with any severe and/or uncontrolled diseases, including: 1) >= Grade 2 myocardial ischemia, myocardial infarction, congestive heart failure (New York Heart Association [NYHA] classification), arrhythmias requiring treatment (including screening QTc>=480ms), and uncontrolled hypertension within 6 months prior to the start of study treatment; 2) Active or uncontrolled severe infections (>=CTCAE grade 2) or unexplained fever >38.5°C within 28 days prior to the start of study treatment; 3) Cirrhosis, active hepatitis*; Active hepatitis (for hepatitis B reference: HBsAg positive, and HBV DNA test value exceeds the upper limit of normal; for hepatitis C reference: HCV antibody positive, and HCV viral load exceeds the upper limit of normal); Note: Subjects meeting the inclusion criteria who are HBsAg positive, anti-HBc positive, or hepatitis C patients must continue antiviral therapy to prevent viral reactivation. 4) Renal failure requiring hemodialysis or peritoneal dialysis; 5) History of immunodeficiency, including HIV positive status or other acquired or congenital immunodeficiency diseases, or history of organ transplantation or hematopoietic stem cell transplantation. 4. Tumor-related symptoms and treatment: (1) Conditions with visceral crisis; (2) Clinical evidence or history of central nervous system (CNS) metastasis and/or carcinomatous meningitis, leptomeningeal disease; (3) Severe bone damage caused by tumor bone metastasis, including pathological fractures in major sites that occurred within 6 months or are expected to occur soon, and spinal cord compression; (4) Chemotherapy received within 3 weeks before the start of the study treatment, radiotherapy received within 2 weeks before the start of the study treatment (except for palliative radiotherapy to non-target lesions), endocrine therapy or other anti-tumor therapy (the washout period is counted from the end date of the last treatment); (5) Unc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS);Overall survival (OS);Clinical benefit rate (CBR);Duration of Relief (DOR);The incidence and severity of adverse events (AE) and serious adverse events (SAE);Abnormal laboratory test values; | — |
Countries
China
Contacts
Public ContactTao Sun
Liaoning Cancer Hospital & Institute
Outcome results
None listed