Breast cancer
Conditions
Interventions
Case series:pyronitib
Sponsors
Ganzhou Cancer Hospital?The Third Hospital of Nanchang
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female patients aged 18 to 75 years old; 2. ECOG score 01; 3. Known hormone receptor status (ER and PR); 4. Primary infiltrating lesions and lymph nodes of the breast must meet the following conditions at the same time: 1) Invasive breast cancer confirmed by histology; 2) Patients who have received radical resection of breast cancer or breast-conserving surgery, and patients who have received breast-conserving surgery must be confirmed by pathological examination that there is no residual invasive carcinoma and ductal carcinoma in situ at the resection margin; the resection margin allows residual lobular carcinoma in situ 3) For patients who did not receive neoadjuvant therapy, postoperative pathological examinations revealed lymph node metastasis (including lymph node micrometastasis); for patients who received neoadjuvant therapy, postoperative pathology showed residual invasive cancer in breast or axillary lymph nodes; 4) A HER2 pathological test result is positive, which is defined as a person whose immunohistochemistry (IHC) test result is 3+ or an in situ hybridization (ISH) result is HER2 gene amplification (HER2/CEP17>=2.0 or average HER2 copy number/cell >=6); 5. The functional level of organs must meet the following requirements: (according to the standards of each branch center) 1) Blood routine: WBC>=4.0x10^9/L; ANC>=1.5x10^9/L; PLT>=100x10^9/L; Hb>=90 g/L; 2) Blood biochemistry: TBIL=50 mL/min (Cockcroft-Gault formula); 6. Heart color Doppler ultrasound: LVEF>=50%; 7. 12-lead ECG: QT interval corrected by Fridericia method (QTcF) <470 ms; 8. For female patients who have not undergone menopause or have not undergone surgical sterilization: during the treatment period and at least 7 months after the last administration in the study treatment, agree to abstain from sex or use an effective method of contraception; 9. Volunteer to join the study, sign an informed consent form, have good compliance and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: Exclusion criteria: Those who have one of the following conditions are not selected as subjects: 1. The presence of breast cancer recurrence and metastasis confirmed by imaging or pathology; 2. Those who have used pyrotinib in the adjuvant treatment phase; 3. Inability to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect the administration and absorption of drugs; 4. Participated in other drug clinical trials within 4 weeks before enrollment; 5. At the same time receiving any other anti-tumor therapy for any tumor; 6. Suffered from other malignant tumors in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma; 7. Have ever suffered from any heart disease, including: (1) Arrhythmia requiring medication or clinical significance; (2) Myocardial infarction; (3) Heart failure; (4) Anyone judged by the researcher as unsuitable for participation Other heart diseases in this test; 8. The cumulative use of patients who have previously received anthracyclines in the neoadjuvant and adjuvant treatment stages exceeds the following regulations: the cumulative dose of doxorubincin exceeds 400mg/m2; the cumulative dose of epirubicin exceeds 800mg/ m2 (if other anthracyclines are used, this amount shall be converted); 9. Those who are known to have a history of allergies to the drug components of this program; have a history of immunodeficiency, including positive HIV testing, active hepatitis B/C or other acquired or congenital immunodeficiency diseases, or organ transplantation History 10. Have a clear history of neurological or mental disorders, including epilepsy or dementia; 11. Female patients during pregnancy and lactation, female patients with fertility and a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures during the entire test period; 12. According to the judgment of the investigator, there are accompanying diseases that seriously endanger the safety of the patient or affect the completion of the study (including but not limited to severe hypertension that cannot be controlled by drugs, severe diabetes, active infection, thyroid disease, etc.); The researcher believes that the patient is not suitable to participate in any other situations in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IDFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DFS;DDFS;safety; | — |
Countries
China
Contacts
Public ContactXingwei Huang, Chunwei Xie
Ganzhou Cancer Hospital
Outcome results
None listed