breast cancer
Conditions
Interventions
Experimental group:Tigeo
control group:none
Sponsors
First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) aged between 18 and 70 years; 2) the ecog ps score of physical state was less than 2; 3) sign informed consent; 4) luminal b1/her-2 negative type (excluding her-2 positive) and trinegative type primary invasive ductal carcinoma of breast were confirmed by pathology, and luminal b1 type satisfied klp-pi = 2 (klp-pi=1.0 × ki-67 li (0/1) 1.5 × ln (0/1) 1.0 × pr status (0/1) or lymph node positive = 4; The triple negative type satisfies ki-67 = 30 and primary lesion = 3cm (or lymph node positive = 1); 5) improve the whole body examination except distant metastasis of tumor; 6) consent to contraception during treatment; 7) the subjects must have good organ function, including the following laboratory examination requirements: normal cardiac function, normal left ventricular ejection fraction (baseline lvef = 50%), white blood cell = 4.0 × 10^9/L, neutrophils count (anc) = 1.5 × 10^9/L; (uln); aspartate transaminase (ast) = 2.5 × uln; alanine aminotransferase (alt) = 2.5 × uln; total bilirubin = 1.5 × uln; serum creatinine = 1.5 × uln.
Exclusion criteria
Exclusion criteria: 1) her-2 positive and luminal a type were confirmed by breast biopsy pathology; 2) iv stage breast cancer, recurrent and metastatic breast cancer; 3) pregnant and lactating patients; 4) have a history of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation); 5) patients with peripheral nervous system disorders caused by diseases or those with obvious mental disorders and central nervous system disorders; 6) there are uncontrolled infections, thrombosis, bleeding risk, etc.; 7) there are chronic diseases which are not well controlled, such as diabetes mellitus, hypertension, peptic ulcer, chronic hepatitis, mental illness, etc.; 8) severe liver disease (such as liver cirrhosis), nephropathy, respiratory diseases, or uncontrolled diabetes; 9) apart from cured basal cell carcinoma of the skin and cured carcinoma in situ of the cervix, the disease-free period of other cancers is less than 5 years; 10) Cardiac diseases with obvious abnormal ekg or obvious clinical symptoms, i.e. congestive heart failure, coronary heart disease with obvious symptoms, arrhythmias that are difficult to control by drugs, or those with myocardial infarction or cardiac function of iii or iv grade within 12 months, or lvef < 55; 11) allergy to experimental drugs; 12) the researchers did not consider it appropriate to carry out the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5 years DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 5 years OS;safety; | — |
Countries
China
Contacts
Public ContactOuchen Wang
First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed