Breast Cancer
Conditions
Interventions
Group 1 :Pyrotinib dose escalation 1
Group 2:Pyrotinib dose escalation 2
Group 3:Pyrotinib + Loperamide
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged >= 18 years and <= 75 years old; 2. Histopathologically confirmed HER2+ invasive breast cancer (HER2+: HER2IHC3+, orIHC2+ and ISH+); 3. Clinical stage: II-III stage; 4. Have received radical resection or breast-conserving surgery for breast cancer; 5. Lymph node metastasis confirmed by postoperative pathology; 6. No local recurrence or metastatic disease; 7. ECOG score 0-1; 8. Have received neoadjuvant and/or adjuvant therapy in the past. If you have received neoadjuvant therapy, you must complete at least 4 cycles of treatment and the drug regimen must include chemotherapy and anti-HER2 therapy; the end of adjuvant trastuzumab treatment <= 1 year; Previously allowed to use Pertuzumab treatment; 9. Known hormone receptor status; 10. Qualified hematology and organ function; 11. Must be willing to use appropriate contraceptive methods during the study; 12. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Local or regional recurrent disease has occurred; 2. The clinical stage is stage IV (metastatic) and bilateral breast cancer; 3. Any history of malignant tumors other than breast cancer in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma; 4. Previously received treatment including pyrotinib, lapatinib, neratinib or other tyrosine kinase inhibitors, as well as other anti-tumor biological therapy or tumor immunotherapy; 5. Accepting anti-tumor therapy in other clinical trials at the same time, including endocrine therapy, bisphosphonate therapy or immunotherapy; 6. Received major surgery not related to breast cancer within 4 weeks before randomization, or the patient has not fully recovered from such surgery; 7. Severe heart disease or discomfort; 8. Inability to swallow, intestinal obstruction or other factors affecting drug taking and absorption; 9. Female patients who are pregnant or breastfeeding, female patients who are fertile and have a positive baseline pregnancy test; 10. Any other situation that the investigator thinks that the patient is not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Grade 3 or higher diarrhea; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse events;Incidence of other adverse events;Incidence of diarrhea;Invasive Disease-Free Survival (iDFS);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactHongyuan Li
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed