Breast cancer
Conditions
Interventions
Control group:Routine periodic review without any intensive treatment
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female, age = 18 years, = 70 years; 2. The primary infiltrating lesions and lymph nodes of the breast must meet the following conditions at the same time: 1) Invasive breast cancer confirmed by histopathology; 2) Clinical staging: II-III; 3) HER2 pathological test result is positive, HER2 positive is defined as immunohistochemistry (IHC) test result is 3+or in situ hybridization (ISH) test positive; 4) Have received radical resection or breast conserving surgery for breast cancer: 5) Postoperative pathology confirmed lymph node metastasis; 6) No recurrent and metastatic disease occurred after the end of adjuvant treatment. 3. There is no limit to the adjuvant/neoadjuvant chemotherapy scheme, but it needs to be confirmed by pathology that HER2 is positive, lymph node is positive, and the number of positive lymph nodes is unlimited before the adjuvant treatment and after the end of neoadjuvant chemotherapy (radical surgery or breast conserving surgery for breast cancer within 4 weeks); 4. In the previous stage of adjuvant/neoadjuvant chemotherapy, it is required to combine trastuzumab ± patouzumab or neoadjuvant therapy regimen containing pyrrolitinib, among which, there is no limit to adjuvant/neoadjuvant chemotherapy regimen, neoadjuvant chemotherapy regimen needs to complete at least 4 cycles (three week regimen) or 9 weeks (weekly regimen), and neoadjuvant anti HER2 therapy needs to complete at least 3 cycles (three week regimen) or 9 weeks (weekly regimen); 5. At random, the distance from the last treatment of trastuzumab = 1 year; 6. It is allowed to use other anti HER2 targeted drugs (only including domestic or imported trastuzumab, pyrrolitinib, and patstuzumab) at the stage of neoadjuvant chemotherapy; 7. Postoperative adjuvant chemotherapy, adjuvant endocrine therapy and adjuvant radiotherapy are allowed; 9. ECOG physical condition score is 0 to 1 (see Appendix I for ECOG score); 10. Known hormone receptor status (ER and PR); 11. At least one time, it is confirmed by pathology that HER2 is positive in the primary breast or axillary metastasis and Ki-67 = 15%, wherein HER2 positive is defined as: HER2 (3+) detected by immunohistochemistry or fluorescence in situ hybridization (FISH) is positive; 12. Hematology examination and blood biochemical examination shall meet the following requirements: WBC = 4.0 × 109/L, neutrophil count (ANC) = 1.5 × 109/L, platelet count (PLT) =100 × 109/L Hemoglobin (Hb) = 90g/L; Total bilirubin (TBIL) = 1.5 × Upper limit of normal value (ULN), AST (sGOT)ALT(sGPT)=1.5 × ULN, urea nitrogen (BUN)=1.5 × ULN, creatinine (Cr) = 1.5 × ULN 13. Creatinine clearance rate = 50mL/min (Cockcroft Gault formula); 14. Color Doppler echocardiography should meet the left ventricular ejection fraction (LVEF)=50% 15. 12 lead ECG examination indicates Fridericia correction QT interval (QTcF)<470ms; 16. Subjects volunteered to join the study, signed the informed consent form, had good compliance and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating patients, patients with fertility and positive baseline pregnancy test, or women of childbearing age who are unwilling to take effective contraceptive measures during the whole test period; 2. Patients with breast cancer recurrence and metastasis confirmed by imaging or pathology before enrollment; 3. Participated in other clinical trials within 4 weeks before grouping; 4. Inability to swallow, chronic diarrhea and intestinal obstruction, and there are many factors affecting drug administration and absorption; 5. There is still cancer residue or positive margin after operation; 6. Disease progression occurs in the process of new adjuvant therapy; 7. Pyrrolidine was used in the adjuvant treatment stage; 8. People known to have a history of allergy to the drug components of this protocol; 9. Have a history of immunodeficiency, including HIV test positive, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 10. Have ever suffered from any heart disease, including angina pectoris, arrhythmias requiring drug treatment or having clinical significance, myocardial infarction, heart failure, and any other heart disease judged by the investigator as unsuitable for this trial; 11. Cured basal cell carcinoma of skin, squamous cell carcinoma of skin and carcinoma in situ of cervix with previous history of other malignant tumors except; 12. According to the investigator's judgment, there are concomitant diseases (including but not limited to hypertension, serious diabetes, active infection, thyroid disease, etc.) that seriously endanger the patient's safety or affect the patient's completion of the study; 13. Have a clear history of neurological or mental disorders, including epilepsy or dementia; 14. The cumulative use of anthracycline drugs in the new adjuvant and adjuvant treatment stages exceeded the following provisions: the cumulative use of doxorubicin exceeded 400mg/m2; The cumulative amount of epirubicin exceeds 800 Mg/m2 (if other anthracycline drugs are used, this amount shall be converted); 15. Any other circumstance that the investigator thinks the patient is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival without invasive disease; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival;No distant transfer of survival time;Overall survival; | — |
Countries
China
Contacts
Public ContactZeng Jian
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed