Breast cancer
Conditions
Interventions
Cohort A:Pyrrolitinib (D1-365, 400mg, qd, for a total of 52 weeks)
Albumin paclitaxel (125mg/m2, D1, 8, q3w, 6 cycles in total)
Loperamide (D1-7, 4mg, tid, D8-21 days 4mg, bid, subsequent use as neede
Cohort B:Pyrrolitinib (D1-21, 320mg, qd
D22-365, 400mg, qd, 52 weeks)
Albumin paclitaxel (125mg/m2, D1, 8, q3w, 6 cycles in total)
Loperamide (D1-7, 4mg, tid, D8-21, 4mg, bid, to be used as needed)
Sponsors
Weihai Municipal Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Participants must meet all of the following inclusion criteria in order to be enrolled in this trial: 1. Histologically confirmed HER2 positive primary invasive breast cancer (T = 3cm, N0/N1mi, M0). 2. Have received radical mastectomy or breast conserving surgery for breast cancer, sentinel lymph node biopsy or axillary lymph node dissection, and the time from breast surgery is = 90 days. 3. Patients who have undergone modified radical surgery or breast conserving surgery must have pathological examination to confirm that there is no residual invasive cancer or ductal carcinoma in situ at the cutting edge. 4. The HER2 pathological test result is positive, following the 2018 ASCO-CAP HER2 positive interpretation guidelines. The pathological laboratory confirms that the immunohistochemical (IHC) score is 3+or 2+, and in situ hybridization (ISH) detection of gene amplification is positive (HER2/CEP17 = 2.0). 5. breast cancer occurring at the same time on both sides requires that the lesions on both sides are HER2 positive by pathological examination. 6. The ER/PR hormone receptor status of the tumor is known. 7. Female patients aged = 18 and = 75 years old. 8. ECOG score is 0-1. 9. The functional level of organs must meet the following requirements: 1) Bone marrow function: Neutrophil count ANC = 1.5 × 109/L; Platelet count PLT = 90 × 109/L; Hemoglobin Hb = 90 g/L; 2) Liver and kidney function: Total bilirubin TBIL = 1.5 × ULN; ALT and AST = 3 × ULN; BUN and serum creatinine Cr = 1.5 × ULN with creatinine clearance rate = 50 mL/min (Cockcroft Gault formula); 3) Cardiac ultrasound: LVEF = 50%; 4) 12 lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method = 480 ms. 10. For female patients who have not experienced menopause or have not undergone surgical sterilization: During the treatment period and within 8 weeks of the last administration during the study treatment, it is agreed to adopt effective non hormonal contraceptive measures. 11. Voluntarily participate in this study, sign informed consent, have good compliance, and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: Those who are unable to participate in the clinical study under any of the following circumstances: 1. Before entering the study, breast cancer had recurred or local recurrence or metastasis was confirmed by radiological examination. 2. Have participated in clinical trials of other drugs within 4 weeks prior to enrollment or within 5 half-lives (whichever is longer). 3. Previously received chemotherapy drugs or tyrosine kinase inhibitors targeting HER2 (such as lapatinib, naratinib, and pyrrolitinib). 4. Other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin. 5. Simultaneously receiving anti-tumor treatment in other clinical trials. 6. Unable to swallow, chronic diarrhea, and intestinal obstruction, there are multiple factors that affect medication administration and absorption. 7. The patient has undergone major surgery unrelated to breast cancer within 4 weeks before enrollment, or has not yet fully recovered from such surgery. 8. Individuals with a known history of allergies to the drug components of this protocol; Have a history of immunodeficiency, including HIV testing positive, HCV, active hepatitis B, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation. 9. Pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test results, or female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial period. 10. Have ever suffered from any heart disease, including: (1) Arrhythmias that require medication treatment or have clinical significance; (2) Myocardial infarction; (3) Heart failure; (4) Any other heart disease determined by the researcher as unsuitable for participation in this trial. 11. According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study (including but not limited to severe hypertension beyond the control of drugs, severe diabetes, active infection, etc.). 12. Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia. 13. Accompanying the use of CYP3A4 inhibitors or inducers, or using drugs that prolong the QT interval 14. Any other circumstances in which the researcher deems the patient unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| iDFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DFS;RFS;DMFS;DDFS; | — |
Countries
China
Contacts
Public ContactQin Chunxin
Weihai Municipal Hospital
Outcome results
None listed