HER2-positive breast cancer
Conditions
Interventions
Experimental group:Neoadjuvant treatment with pyrrotinib maleate combined with trastuzumab and albumin paclitaxel
Sponsors
Tumour Hospital of Mudanjiang City
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged 18-75 years; 2. ECOG PS: 0-1 score; 3. The estimated survival time is not less than 12 weeks; 4. Breast cancer meets the following criteria: invasive breast cancer confirmed by histology, and the diameter of the primary tumor determined by the standard evaluation method in the research center is > 2cm; Tumor stage: early stage (T2-3, N0-1, M0) or locally advanced stage (T2-4, N2, N3, M0); 5. Her2-positive breast cancer confirmed by pathology; 6. Hormone receptor status (ER and PR) is known; 7. Normal function of major organs means that the following criteria are met: (1) Blood test neutrophil (ANC) >=1.5x10^9/L; Platelet count (PLT) >=90x10^9/L; Hemoglobin (Hb) >=90g/L; (2) Total bilirubin (TBIL) =55%; (4) The QT interval (QTcF) corrected by Fridericia method was less than 470msec in 12-lead ECG; 8. For women who have not undergone menopause or surgical sterilization: consent to abstinence or use an effective contraceptive method (during treatment and for at least 7 months after the last dose in the study treatment); 9. Volunteer to participate in this study, sign the informed consent, have good compliance and be willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Stage IV (metastatic) breast cancer; 2. Inflammatory breast cancer; 3. Previous or co-existing other malignant tumors, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 4. Pregnant or lactating patients; 5. A history of congestive heart failure (CHF) or uncontrolled heart disease (angina, arrhythmia, hypertension); 6. Participated in clinical trials of other antitumor drugs within four weeks; 7. Multiple factors affecting oral medication (e.g., inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction); 8. Patients with allergies or known history of allergies to the drug components of this protocol; A history of immunodeficiency, including being HIV positive, or having other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 9. Patients with active infection and severe mental illness; 10. Concomitant diseases that, in the judgment of the investigator, seriously endanger the patient's safety or interfere with the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease-free survival time;objective response rate;distant disease free survival; | — |
Countries
China
Contacts
Public ContactShao Bin
Outcome results
None listed