Brest Cancer
Conditions
Interventions
Experimental group:Pyrotinib Maleate Tablets Combined With Albumin-bound Paclitaxel and Trastuzumab
Sponsors
West China Hospital of Sichuan Universty
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged 18 to 70 years who were newly treated; 2. ECOG systemic state 0~1; 3. According to the RECIST 1.1 , at least one measurable lesion exists; 4. Patients with HER2-positive breast cancer confirmed by pathological examination, clinical stage II-III [cT2 and any N, cT3 and any N; cT4 and any N, according to American Joint Committee on Cancer (AJCC) standards]; 5. The functional level of organs must meet the following requirements: (1) Blood routine: 1) ANC >= 1.5x10^9/L; 2) PLT >= 90x10^9/L; 3) Hb >= 90 g/L; (2) Blood biochemistry: 1) TBIL = 50%; (4) 12-lead ECG: Fridericia corrected QT interval (QTcF) female < 470 ms. 6. Known the hormone receptor status; 7. The serum pregnancy test is negative and patients with reproductive potential must agree to use effective non-hormonal contraceptive methods during treatment and at least 6 months after the last use of the test drug; 8. Volunteer to join the study, sign informed consent, have good compliance and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with inflammatory breast cancer. 2. Patients with metastatic breast cancer (stage IV). 3. Inability to swallow, chronic diarrhea and intestinal obstruction, as well as other factors that affect the administration and absorption of the drug. 4. At the same time receive anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy. 5. Have received major surgery not related to breast cancer within 4 weeks before enrollment, or have not fully recovered from the surgery. 6. Previously used or currently using anti-HER2 targeted drugs (including trastuzumab, pertuzumab, lapatinib, neratinib and pirotinib, etc.). 7. 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. 8. Accept any other anti-tumor therapy at the same time. 9. Those who are known to have a history of allergies to the drug components of this program; have a history of immunodeficiency, including a positive HIV test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation. 10. Previously suffering from heart diseases, including: (1) Angina pectoris; (2) Arrhythmia requiring medication or clinical significance; (3) Myocardial infarction; (4) Heart failure; (5) Judged by the investigator other heart diseases that are not suitable for participating in this trial. 11. Female patients during pregnancy and lactation;The pregnancy test is positive;Female patients of childbearing age who are unwilling to take effective contraceptive measures during the trial. 12. According to the judgment of the investigator, there are concomitant 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, etc.). 13. Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia. 14. Concomitant use of CYP3A4 inhibitors or inducers. 15. The investigator judges that it is not suitable to participate in any other situations in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate ;Disease Control Rate;Complete remission rate of breast pathology ;Safety; | — |
Countries
China
Contacts
Public ContactLuo Ting
West China Hospital of Sichuan University
Outcome results
None listed