HER2-positive breast cancer
Conditions
Interventions
Experimental group:Eribulin combined with carboplatin, trastuzumab and pertuzumab for treatment
Control group:TCbHP regimen (docetaxel + carboplatin + trastuzumab + pertuzumab) for treatment
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years old inclusive, female patients with curable breast cancer who are capable of signing informed consent, with expected survival >= 3 months; 2. Histologically confirmed invasive breast cancer; 3. Pathologically confirmed positive HER2 expression (defined as IHC score 3+, or IHC score 2+ with positive HER2 gene amplification confirmed by ISH); 4. ECOG PS score: 0–1; 5. Estrogen receptor (ER) and progesterone receptor (PgR) status available; 6. For females of childbearing potential, serum or urine pregnancy test negative within 7 days prior to enrollment; agree to use effective contraception throughout the study and for 6 months after last study drug administration; 7. Adequate function of major organs meeting the following criteria: (1) Hematology (within 7 days before screening, no blood transfusion or hematopoietic growth factors for correction): Hemoglobin (HGB) >= 90 g/L; Absolute neutrophil count (NEUT) >= 1.5×10^9/L; Platelet count (PLT) >= 100×10^9/L; White blood cell count >= 2.5×10^9/L; (2) Biochemistry: Total bilirubin (TBIL) = 50 mL/min (calculated via Cockroft-Gault formula); (3) Coagulation: Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) = 55%; 12-lead ECG QTc interval < 470 ms for females; 8. Voluntarily enroll in the study, sign informed consent form, demonstrate good compliance and agree to follow-up visits.
Exclusion criteria
Exclusion criteria: 1.Patients with stage IV metastatic or recurrent breast cancer; 2.Other special types of breast cancer; 3.In the past five years, if one has received any anti-tumor treatment or radiotherapy for any malignant tumor, this does not include cervical carcinoma in situ that has been cured, basal cell carcinoma of the skin, or squamous cell carcinoma. 4.Patients who are currently undergoing other clinical research treatments (excluding those who participated in the overall survival follow-up study); 5.Those who have a history of abusing psychotropic drugs and are unable to quit, or those with mental disorders; 6.Serious heart diseases include but are not limited to: a confirmed history of heart failure or systolic dysfunction (LVEF < 50%); uncontrolled hypertension; a history of myocardial infarction; a history of congestive heart failure classified as NYHA = II, which is not controlled by medication; severe arrhythmias that cannot be controlled by medication (except for atrial fibrillation and paroxysmal supraventricular tachycardia). 7.Those who have a history of allergic reaction to the components of this treatment plan; 8.Have a history of immunodeficiency, including a positive HIV test result, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation; Pregnant or lactating female patients, female patients with reproductive capacity and a positive baseline pregnancy test result, or reproductive-aged patients who are unwilling to take effective contraceptive measures throughout the trial period; 9.The researchers believe that the patient is not suitable for participating in any other aspect of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Pathological Complete Response, tpCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Breast Pathological Complete Response, bpCR;Adverse Events, AE;Treatment-Related Adverse Events, TRAEs;Overall Survival, OS;Event-Free Survival, EFS;Objective Response Rate, ORR;Serious Adverse Events, SAEs;Invasive Disease-Free Survival, iDFS; | — |
Countries
China
Contacts
Public ContactYi Zhang
The First Affiliated Hospital of Army Medical University
Outcome results
None listed