breast cancer
Conditions
Interventions
Group of breast cancer:Inetetamab
Sponsors
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria: 1) Age =18 years old, and =70 years old, female; 2) patients with histologically confirmed unilateral primary invasive breast cancer, excluding occult breast cancer, inflammatory breast cancer and eczematoid carcinoma; 3) HER-2 positive (defined as +++ by immunohistochemistry or positive by in situ hybridization); 4) mass =2cm or lymph node positive; 5) at least one assessable target lesion according to response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; 6) ECOG performance status =2; 7) LVEF=55 %; 8) Brain natriuretic peptide (BNP) (or N-terminal pro-brain natriuretic peptide (NT-proBNP)) and cardiac troponin were within the normal range; 9) AST and ALT=2 times upper limit of normal, alkaline phosphatase =2 times upper limit of normal, total bilirubin =2 times upper limit of normal; Serum creatinine =1.5 times upper limit of normal; 10) adequate bone marrow functional reserve: white blood cell count =3.0×109 /L, neutrophil count =1.5×109 /L; Platelet count =100×109 /L; Hemoglobin =90 g/L; 11) able to understand the study process, voluntarily participate in this study, and sign informed consent.
Exclusion criteria
Exclusion criteria: Subjects may not participate in the study if they have any of the following: 1) Stage IV (metastatic) breast cancer; 2) patients with a known allergy to the active ingredient or other ingredient of the study drug. 3) other antineoplastic therapy (except ovarian function inhibitors) during neoadjuvant therapy as judged by the investigator. 4) patients with severe heart disease or discomfort who are expected to be unable to tolerate chemotherapy, including but not limited to: a. Fatal arrhythmia or higher-grade AV block (second-degree Mobitz 2 AV block or third-degree AV block) b. Unstable angina pectoris. c. Clinically significant valvular heart disease. d. Electrocardiogram showed transmural myocardial infarction. e. Uncontrolled hypertension 5) poorly controlled diabetes. 6) serious or uncontrolled infections, including but not limited to active hepatitis virus infection, positive human immunodeficiency virus (HIV) antibody, pulmonary infection, etc., that may affect study treatment or assessment of study results. 7) history of other malignant tumors in the past 5 years (except cured cervical carcinoma in situ or skin basal cell carcinoma). 8) participated in another clinical trial within 4 weeks before study initiation. 9) pregnant or lactating women or women of childbearing age who refused to use effective contraception during the study period. 10) The patient had any other condition considered by the investigator to be inappropriate for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate after neoadjuvant chemotherapy (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate after neoadjuvant chemotherapy (ORR, CR+PR);Difference of pCR and ORR rates in patients with different subtypes of CD16A 158F allele;Percentage of tumor reduction after neoadjuvant chemotherapy;Rate of breast-conserving surgery; | — |
Countries
China
Contacts
Public ContactLiang Jin
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Outcome results
None listed