breast cancer
Conditions
Interventions
Test group:Neoadjuvant therapy group using pyrotinib combined with trastuzumab
Test group:Neoadjuvant therapy with trastuzumab combined with pertuzumab
Test group:Combination therapy of pyrotinib and trastuzumab as adjuvant therapy
Sponsors
Henan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age = 18 years old; 2. Invasive breast cancer with clinical stage ? - ? and surgical treatment; 3. Histopathological confirmation of HER-2 positivity: Immunohistochemistry (IHC) results show 3+or in situ hybridization (ISH) results show HER-2 gene amplification (HER-2/CEP17 >=2.0 or average HER-2 copy number/cell >= 6); 4. The primary infiltrating lesions and lymph nodes of the breast must simultaneously meet the following conditions: 4.1) Having received radical resection or breast conserving surgery for breast cancer, sentinel lymph node biopsy or axillary lymph node dissection, it must be confirmed by pathological examination that there is no residual invasive cancer at the cutting edge and residual ductal carcinoma in situ; The margin allows for residual lobular carcinoma in situ; 4.2) The distance from breast surgery is =1.5 × 10^9/L; Platelet count (PLT) >= 90 × 10^9/L; Hemoglobin (Hb) >= 90 g/L; (2) Blood biochemistry: Total bilirubin (TBIL) = 55%; (4) 12 lead electrocardiogram: The Fridericia corrected QT interval (QTcF) is less than 470 milliseconds. 8. For female patients who have not undergone menopause or surgical sterilization: agree to abstinence or use effective non hormonal contraceptive methods during the treatment period and within 8 weeks after the last dose during the study treatment; 9. Researchers believe that there may be benefits; 10. Voluntarily participate in the study, sign an informed consent form, have good compliance, and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. breast cancer had recurred before entering the study or local recurrence or metastasis was confirmed by radiological examination; 2. Within the first 4 weeks or 5 half lives (whichever is longer) before enrollment, have participated in clinical trials of other drugs and received anti-tumor therapy, including endocrine therapy or immunotherapy; 3. Bilateral breast cancer; 4. History of any malignancy other than breast cancer in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma; 5. The patient has undergone major surgical procedures unrelated to breast cancer within 4 weeks before enrollment, or has not fully recovered from such surgical procedures; 6. Inability to swallow, intestinal obstruction, or other factors that affect medication administration and absorption; 7. Known history of allergies to pyrotinib or excipients, or drugs with similar chemical structures or categories to pyrotinib; 8. Those with a history of gastrointestinal diseases, with diarrhea as the main symptom; 9. Any evidence of serious or uncontrollable systemic diseases, including uncontrolled hypertension, active bleeding disorders, active infections, including hepatitis B, C, and human immunodeficiency virus, or severe impairment of bone marrow reserve or organ function, including liver and kidney damage, which in the eyes of researchers will greatly alter the balance of benefits/risks; 10. Patients with a history of confirmed neurological or psychiatric disorders, including those without autonomous behavior ability or suffering from mental illness; 11. Have suffered from any heart disease, including: Arrhythmias that require medication or have clinical significance; Myocardial infarction; Heart failure; Any other heart disease or condition that the researcher deems unsuitable for participation in this trial. 12. Pregnant or lactating female patients; 13. The researcher believes that the patient is not suitable to participate in any other circumstances of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non invasive recurrence survival period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease-free survival period;Survival period without distant metastasis;Safety indicators; | — |
Countries
China
Contacts
Public ContactYu Yang; You Wei
Henan Provincial People's Hospital
Outcome results
None listed