Breast cancer
Conditions
Interventions
treatment group:eribulin + trastuzumab + pertuzumab
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily participated in this study, signed the informed consent form, and had good compliance; 2. Age: 18 - 75 years old (at the time of signing the informed consent form); ECOG PS score: 0 - 1 point; Expected survival period: more than 3 months; 3. Patients with primary breast cancer confirmed by pathological histology or cytology; 4. Stage II-IIIC of the 8th edition breast cancer TNM classification (T2-T4 plus any N, or any T plus N1-3, M0), locally advanced, inflammatory or early, unilateral, and with histologically confirmed invasive breast cancer; Inflammatory breast cancer patients must be able to undergo core needle biopsy; 5. Confirmed as HER-2 positive by the central laboratory; 6. Non-lactating patients. The serum or urine pregnancy test was negative within 7 days before the study enrollment; For pregnant women subjects, they must agree to use effective contraceptive methods during the study and within 6 months after the last administration of the study drug; 7. Good organ function, meeting the following criteria: Blood routine examination criteria (within 7 days before screening, no blood transfusion, no use of hematopoietic stimulating factor drugs to correct): a. Hemoglobin (HGB) >= 90g/L ; b. Absolute neutrophil count (NEUT) >= 1.5×10^9/L ; c. Platelet count (PLT) >= 100×10^9/L ; d. White blood cell >= 2.5×10^9/L; Biochemical examination needs to meet the following criteria: a. Total bilirubin (TBIL) = 50 ml/min (creatinine clearance rate calculated according to the Cockroft-Gault formula); Coagulation function examination needs to meet the following criteria: Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) <= 1.5×ULN (no anticoagulation treatment received), if the patient is receiving anticoagulation treatment, as long as PT is within the range prescribed by the anticoagulant drug, it is acceptable.
Exclusion criteria
Exclusion criteria: 1. Patients with distant metastatic breast cancer; 2. Other special types of breast cancer; 3. Those who have received anti-tumor treatment or radiotherapy for any malignant tumor within the past five years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma; 4. Patients who are currently undergoing other clinical research treatments (except for patients whose overall survival follow-up is involved in a study); 5. Those with a history of substance abuse of psychotropic drugs and unable to quit or those with mental disorders; 6. Severe heart diseases including but not limited to: uncontrolled hypertension; history of myocardial infarction; history of congestive heart failure classified as NYHA = II, severe arrhythmias that cannot be controlled by medication (except for atrial fibrillation and paroxysmal supraventricular tachycardia); 7. Those who have a known history of allergy to the components of this drug regimen; 8. Pregnant or lactating women patients, women with reproductive capacity and those whose baseline pregnancy test is positive, or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| breast pathological complete response rate;objective Response Rate;disease control rate;3-year event-free survival rate;3-year invasive diseases free survival rate;security; | — |
Countries
China
Contacts
Public ContactHu Hai, Yu Yang
Breast Center of Zhejiang Cancer Hospital
Outcome results
None listed