Breast cancer
Conditions
Interventions
Experimental group:All patients received treatment with propranolol hydrochloride, starting 1 week before neoadjuvant chemotherapy: an initial dose of 20mg BID, continued for 3 days to confirm drug to
if stability criteria were not met, 20mg BID was maintained. This dosage continued until the end of neoadjuvant treatment and was continued postoperatively until tumor progression (according to RECIST
Sponsors
Anhui provincial cancer hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any test-related processes; 2. Female, 18~75 years old; 3. Patients with locally advanced/metastatic breast cancer diagnosed by histopathology, with clinical stage ?B-?C (AJCC 8th edition) or inoperable; 4. According to the definition of response evaluation Criteria 1.1 (RECIST1.1) for solid tumors, patients must have measurable lesions; 5. Agree to provide formalin-fixed tumor tissue samples or fresh biopsy tumor focus tissues for marker detection; 6.ECOG score 0-1; 7. The expected survival time is >=6 months; 8. Sufficient organ function, no serious abnormal hematopoietic function, abnormal heart, lung, liver, kidney function and immune deficiency, and the subjects should meet the following laboratory indicators: 1) Hemoglobin (HGB) >= 90g/L; 2) Neutrophil (NEUT)>=1.5×10^9/L or white blood cell count (WBC) >= 3× 10^9/L; 3) Platelet (PLT) >= 90× 10^9/L; 4) aspartate aminotransferase (AST) <= 2.5× ULN; 5) Alanine aminotransferase (ALT) <=2.5× ULN; 6) Total bilirubin (TBIL) <= 1.5× ULN; Serum creatinine (SCr)<=1.0×ULN;
Exclusion criteria
Exclusion criteria: 1. Other malignant diseases (excluding radical basal cell carcinoma of skin, squamous epithelial carcinoma of skin, and/or radical resection of carcinoma in situ) were diagnosed within 5 years before the first administration; 2. Currently participating in interventional clinical research treatment, or receiving other research drugs or using research equipment within 4 weeks before the first administration; 3. Previously received radiotherapy, systemic chemotherapy, tumor targeted therapy and immunotherapy for breast cancer; 4. Symptomatic or uncontrolled brain metastases that require simultaneous treatment, including but not limited to surgery, radiation and/or corticosteroids, or clinical manifestations of spinal cord compression; 5. At present, oral or intravenous beta blockers (such as atenolol, bisoprolol, carvedilol, labetalol, metoprolol, Nadolol, Sotalol and other beta blockers) cannot be safely switched to propranolol; 6. There are contraindications to the use of beta blockers; 7. The study was receiving systemic glucocorticoid therapy (excluding local glucocorticoid by nasal spray, inhalation or other routes) or any other form of immunosuppressive therapy within 7 days before the first administration; Note: Physiological dose of glucocorticoid (prednisone =10 mg/ day or equivalent drug) is allowed; 8. There is clinically uncontrollable pleural effusion/peritoneal effusion (patients who don't need drainage or stop drainage for 3 days without obvious increase in effusion can be enrolled); 9. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 10. Those who are known to be allergic to paclitaxel/paclitaxel liposome, cyclophosphamide, propranolol hydrochloride active ingredients or auxiliary materials; 11. Before starting the treatment, they have not fully recovered from the toxicity and/or complications caused by any intervention measures (i.e. = 2; 3) Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before being selected for treatment; 4) blood pressure control is not ideal (systolic blood pressure > 140mmhg or 90mmhg or < 60mmhg); 5) There is a history of non-infectious pneumonia requiring
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| CRS3 score;R0 resection rate;Objective Response Rate;Overall survival rate;Incidence rate of adverse events;PD-L1;MSS status;ß2-AR;Immune cell subsets;Pain score;Heart rate;Blood pressure;Sleep quality score;Cortisol;5- HT;Corticotrophin;Norepinephrine; | — |
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission (pCR) rate;Anxiety score; | — |
Countries
China
Contacts
Public ContactKuojun Ren
Anhui provincial cancer hospital
Outcome results
None listed