Breast Cancer
Conditions
Interventions
Fixed dose group:TCbHP neoadjuvant regimen based on a first loading dose of 480mg and a maintenance dose of 360mg trastuzumab (Henlius).)
Sponsors
First Affiliated Hospital of Xi’an Jiaotong University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female, 18-65 years old, diagnosed as breast cancer, with negative immunohistochemical hormone receptor (ER -, PR -), HER2+++or HER2++FISH detection indicating HER2 amplification; 2. Clinical TNM staging is stage II-IIIa; 3. Breast magnetic resonance imaging evaluates that the breast lesion is unilateral or single lesion, with a diameter greater than 20mm; 4. ECOG score of 0 or 1; 5. No peripheral neuropathy; 6. Have sufficient baseline bone marrow and organ functional reserves, specifically: neutrophil absolute value>=1500/mm3, platelet count>=100000/mm3, and hemoglobin concentration>=8g/dl; Serum creatinine=50%. 7. Sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Poor organ function (heart function: LEVF 1.5 times the upper limit of normal value; ASAT and ALAT>1.5 times the upper limit of normal, alkaline phosphatase >2.5 times the upper limit of normal, total bilirubin >1.5 times the upper limit of normal). 2. Allergic to trastuzumab/pertuzumab, carboplatin or paclitaxel. 3. Previous use of trastuzumab, carboplatin or paclitaxel. 4. Other drugs for the treatment of HER2-positive breast cancer, such as herceptin and traditional Chinese medicine preparations, were used during treatment. 5. Those who need to change the neoadjuvant therapy plan due to the change of the condition during the treatment. 6. Breast cancer patients during pregnancy and lactation. 7. The patient also had a severe systemic disease and/or an uncontrollable infection. 8. Patients with a history of partial mastectomy for previous breast diseases, including lobulated breast tumors. 9. Severe cardiovascular and cerebrovascular disease (e.g., unstable angina pectoris, chronic heart failure, uncontrolled hypertension >150/90 MMGH, myocardial infarction, or cerebrovascular accident) within 6 months. 10. Mental illness, cognitive impairment, inability to understand the trial protocol and side effects, inability to complete the trial protocol and follow-up workers (systematic evaluation is required before trial enrollment). 11.Without personal freedom and independent capacity for civil conduct.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Miller-Payne grade;MRI report; | — |
Countries
China
Contacts
Public ContactCan Zhou
First Affiliated Hospital of Xi’an Jiaotong University
Outcome results
None listed