Breast cancer
Conditions
Interventions
Trial Group:Each neoadjuvant treatment cycle lasts 21 days: on Day 1, trastuzumab and pertuzumab targeted therapy are administered in combination with Huai'er Granules
on Day 2, chemotherapy with docetaxel and carboplatin is given in combination with Huai'er Granules
from Day 3 to Day 21, maintenance therapy with Huai'er Granules continues.
Control group:Each neoadjuvant therapy cycle lasts 2 days: on Day 1, trastuzumab and pertuzumab are administered for targeted therapy
on Day 2, docetaxel and carboplatin are administered for chemotherapy.
Sponsors
The First Affiliated Hospital of Xi 'an Jiaotong University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female, aged 18–70 years, body weight 50–67 kg, diagnosed with breast cancer, immunohistochemistry showing hormone receptor-negative (ER- and PR-), HER2 +++ or HER2 ++ with FISH confirmation of HER2 amplification; 2. Clinical TNM stage II–III; 3. Breast MRI reveals a unilateral, solitary lesion; 4. ECOG performance status of 0 or 1; 5. No peripheral neuropathy; 6. Adequate baseline bone marrow and organ function, defined as: absolute neutrophil count >=1500/mm^3, platelet count >=100,000/mm^3, hemoglobin concentration >=8 g/dL; serum creatinine =50%; 7. Written informed consent signed.
Exclusion criteria
Exclusion criteria: 1. Poor organ function (cardiac function: LVEF 1.5 times the upper limit of normal (ULN); ASAT and ALAT >1.5 times ULN, alkaline phosphatase >2.5 times ULN, total bilirubin >1.5 times ULN); 2. History of allergy to trastuzumab/pertuzumab, carboplatin, or taxane-based drugs; 3. Prior exposure to trastuzumab, carboplatin, or taxane-based drugs; 4. Concomitant use of other drugs for HER2-positive breast cancer, such as pyrotinib or other traditional Chinese medicine formulations, is prohibited during treatment; 5. Patients requiring a change in neoadjuvant treatment regimen due to disease progression during therapy; 6. Pregnant or lactating patients with breast cancer; 7. Patients with concomitant severe systemic diseases and/or uncontrolled infections that preclude enrollment in this study; 8. History of partial mastectomy for prior breast disease, including phyllodes tumor; 9. Severe cardiovascular or cerebrovascular diseases within 6 months prior to randomization (e.g., unstable angina, chronic heart failure, uncontrolled hypertension >=150/90 mmHg, myocardial infarction, or cerebrovascular accident); 10. Presence of psychiatric disorders or cognitive impairment preventing understanding of the trial protocol and its side effects, or inability to complete the trial protocol and follow-up (systematic assessment required prior to enrollment); 11. Lack of personal freedom or independent legal capacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Event-free survival;Overall survival;Safety endpoints (gastrointestinal reactions, hematologic toxicity, etc., >= Grade 3 adverse events); | — |
Countries
China
Contacts
Public ContactZhou Can
The First Affiliated Hospital of Xi 'an Jiaotong University
Outcome results
None listed