Breast Caner
Conditions
Interventions
Mini-PDX Model Testing Group:Subject to Mini-PDX model testing
TCbHP group:TCbHP neoadjuvant regimen based on a first loading dose of 480mg and a maintenance dose of 360mg trastuzumab (Henlius)
Pyrotinib group:TH and pyrotinib neoadjuvant regimen based on a first loading dose of 480mg and a maintenance dose of 360mg trastuzumab (Henlius)
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. voluntarily participate in the clinical study and sign an informed consent form; 2. Female, aged 18-70 years, weighing between 50-67 kg, with a confirmed diagnosis of breast cancer, positive ER (=10% positive) and PR (=10% positive) by immunohistochemistry, HER2 +++ or HER2 ++ by FISH suggestive of HER2 amplification, tested in the Mini-PDX model, on a new trastuzumab (Henlius®)-based female patients on a neoadjuvant regimen based on trastuzumab (Henlius®); 3. clinical TNM stage II-III; 4. an unilateral, solitary breast lesion with a lesion diameter > 20 mm as assessed by breast MRI; 5. patient agrees to undergo surgery when the criteria for surgery are met after neoadjuvant therapy 6. the absence of peripheral neuropathy 7. good function of major organs, meeting the following criteria: a. Routine blood examination criteria (not transfused and not corrected with haematopoietic stimulating factor-like drugs within 14 days prior to randomisation): white blood cell count = 3.0 x 109/L; absolute neutrophil count = 1.5 x 109/L); haemoglobin = 90 g/L; platelets = 100 x 109/L; b. Biochemical examination criteria: aspartate aminotransferase (AST), alanine aminotransferase (ALT) = 2.5 x upper limit of normal (ULN); total bilirubin = 1.5 x ULN, for known cases of Gilberts syndrome total bilirubin = 2 x ULN; alkaline phosphatase = 2.5 x ULN; serum creatinine = 1.5 x ULN. 8. Eastern Cooperative Oncology Group (ECOG) functional status (PS) score = 1 within 7 days prior to first dose. 9.Females of childbearing potential with a negative serum pregnancy test at screening (within 7 days prior to randomisation) or infertile, non-lactating, men and women of childbearing potential following a highly effective method of contraception until 7 months after the study trial/reference drug administration.
Exclusion criteria
Exclusion criteria: 1. inflammatory breast cancer, or stage IV (metastatic) breast cancer, bilateral breast cancer or multicentric (multiple tumours involving more than 1 quadrant) breast cancer; 2. a history of other malignancies within the past 5 years (except cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin which has undergone radical treatment) 3. previous or current systemic anti-tumour therapy (including systemic chemotherapy, molecular targeted drug therapy, biological therapy and other investigational therapeutic agents) for the current breast cancer; 4. participation in another clinical trial within 4 weeks (or 3 months in the case of a monoclonal drug clinical trial) prior to study entry, or intentional participation in another clinical trial throughout the study period 5. a history of serious cardiac disease or medical treatment, including but not limited to the following a. Any previous and current NYHA-eligible heart failure or systolic dysfunction (LVEF 100 beats/min at rest, significant ventricular arrhythmias (e.g. ventricular tachycardia) or advanced AV block (e.g. second degree AV block Mobitz type II or third degree AV block); c. Unstable angina or angina requiring anti-anginal medication; d. ECG showing a history of transmural myocardial infarction; e. clinically significant heart valve disease; f. poorly controlled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg); 6. previous doxorubicin exposure > 360 mg/m2 (or equivalent); Note: Equivalents include epirubicin > 720 mg/m2, mitoxantrone > 120 mg/m2, idarubicin > 90 mg/m2, adriamycin liposomes or other anthracycline antibiotics above 360 mg/m2 doxorubicin equivalents. If more than one anthracycline antibiotic is used, the cumulative dose must not exceed 360 mg/m2 doxorubicin equivalent; 7. People with viral hepatitis infection Subjects with Hepatitis B HbsAg (+) or HBcAb (+) should be tested for HBV- DNA. If HBV- DNA is = 500 IU/ml or 2500copies/ml, they cannot be enrolled. Those with elevated HBV- DNA must agree to receive nucleoside anti-Hepatitis B virus treatment, and those with HBV- DNA reduced to meet the criteria after antiviral treatment during the screening period can be enrolled. HCV-RNA testing is required for those who are HCV-positive and those who are HCV-RNA-positive cannot be enrolled; 8. Human immunodeficiency virus (HIV) infection with positive anti-HIV antibodies; 9. Hypersensitivity to any investigational drug or any component or excipient thereof; 10. have undergone major surgery within 28 days prior to randomisation, which is defined in this study as a procedure that requires at least 3 weeks of post-operative recovery before being able to undergo treatment in this study. Received local radiotherapy, radiofrequency ablation, interventional therapy, etc. (excluding previous diagnostic biopsies) within 2 weeks prior to the first dose; 11. other serious co-morbidities that may interfere with the treatment plan, including severe pulmonary status/disease 12. the subject has any other factors that, in the judgment of the investigator, make him/her unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| pathological complete response rate assessed by study center;breast pathological complete response rate ;objective remission rate;Event-free survival;disease free survival; | — |
Countries
China
Contacts
Public ContactZhou Can
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed