Breast Cancer
Conditions
Interventions
Treatment Group:Eribulin Mesilate+Trastuzumab+Pertuzumab
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Subjects voluntarily participate in the study, sign the informed consent form, are expected to have good compliance, and are willing to cooperate with follow-up. 2.Treatment-naive female breast cancer patients aged >= 18 years and = 90 g/L; Absolute neutrophil count (NEUT) >= 1.5 × 10^9/L; Platelet count (PLT) >= 100 × 10^9/L; White blood cell count (WBC) >= 2.5 × 10^9/L. -Biochemical criteria: Total bilirubin (TBIL) = 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 55%; 12-lead electrocardiogram (ECG): QT interval < 470 ms for female subjects.
Exclusion criteria
Exclusion criteria: 1Patients with Stage IV metastatic or recurrent breast cancer. 2.Patients with other special types of breast cancer. 3.Patients who have received anti-tumor therapy or radiotherapy for any malignant tumor within the past 5 years, excluding cured carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin. 4.Patients who are receiving treatment in other clinical trials (except those enrolled in survival follow-up of a previous study). 5.Patients with a history of psychotropic drug abuse that cannot be abstained from, or with mental disorders. 6.Patients with severe heart diseases, including but not limited to: uncontrolled hypertension; history of myocardial infarction; history of congestive heart failure with New York Heart Association (NYHA) classification >= Grade II; severe arrhythmia uncontrolled by medication (excluding atrial fibrillation and paroxysmal supraventricular tachycardia). 7.Patients with a known history of hypersensitivity to any component of the study drugs. 8.Pregnant or lactating women; women of childbearing potential with a positive baseline pregnancy test; or women of childbearing potential who are unwilling to take effective contraceptive measures throughout the trial period. 9. History of immunodeficiency disorders, including HIV-positive status, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Pathological Complete Response Rate;Breast Pathological Complete Response Rate;Objective Response Rate;Disease Control Rate;Security; | — |
Countries
China
Contacts
Public ContactSong Dong
The First Bethune Hospital of Jilin University
Outcome results
None listed