Breast Cancer
Conditions
Interventions
experimental group:RecurIndex
Sponsors
Breast Surgery of the First Hospital of China Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for this trial: 1. Female patients aged 18-70 years old; 2. ECoG patients with general state 0-1; 3. Patients with breast cancer who meet the following criteria: Histologically confirmed invasive breast cancer Tumor stage: TNM stage II-III 4. Breast cancer patients with negative Er, PR and HER2. The positive threshold of ER and PR immunohistochemistry (IHC) was >=1%, HER2 IHC 0-1 + or IHC 2 + and fish was negative; 5. The expression level of Ki67 in tumor tissue is known before treatment, and the tissue can be used for other biological and molecular detection; 6. Patients who have not received endocrine therapy, radiotherapy and chemotherapy in the early stage; 7. Patients whose main organ function level must meet the following requirements (no blood transfusion, no use of leukocyte and platelet raising drugs within 2 weeks before screening); (1) Blood routine examination: Neutrophil count >=1.5x10^9/l, Platelet count >=100x10^9/L, Hemoglobin >=100 g/L (2) Blood biochemistry TBIL=60ml/min; (3) There was no serious arrhythmia or heart failure; 8. Patients who voluntarily joined the study and signed informed consent had good compliance and were willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: In case of any of the following conditions, the subjects were not selected: 1. Patients with stage IV (metastatic) breast cancer; 2. Patients with inflammatory breast cancer; 3. Patients with other malignant tumors in the past 5 years, excluding those with cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma; 4. Patients who have been treated with chemotherapy, radiotherapy, targeted therapy or other anti-tumor therapy in the early stage; 5. Pregnant or lactating women; 6. Patients with any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that started in the last 3 months, congestive heart failure, myocardial infarction within 12 months before enrollment, severe arrhythmia requiring medical treatment, liver, kidney or metabolic diseases); 7. Patients with peripheral neuropathy >=grade 2 (according to nci-ctcae V5.0); 8. Patients who have been known to have allergic history to the drug components of this regimen; have a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 9. Patients who participated in other clinical trials in the past 30 days; 10. Any other circumstances in which the investigator considers that the patient is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR(Pathological Complete Response); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological response(Miller-Payne G3-5);duration of locoregional control,LRR;duration of freedom from distant metastasis, DMFP;overall survival, OS; | — |
Countries
China
Contacts
Public ContactBo.Chen
The First Affiliated Hospital of China Medical University
Outcome results
None listed