Breast cancer
Conditions
Interventions
Pyratinib+trastuzumab group:Pyratinib, 400mg po qd, 3 weeks per cycle, 14 cycles in total
Trastuzumab, 6mg/kg iv q3w, 3 weeks per cycle, 14 cycles in total.
Patutuzumab+trastuzumab group:Patutuzumab,Loading 840mg, maintenance 420mg, iv q3w, 3 weeks per cycle, 14 cycles in total
Trastuzumab, 6mg/kg iv q3w, 3 weeks per cycle, 14 cycles in total
Sponsors
Suining Central Hospital/West China Hospital of Sichuan University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female. 2. Aged from 18 to 70 years. 4. HER2-positive invasive breast cancer was diagnosed by histology. 5. Received neoadjuvant therapy, and included at least 4 cycles of chemotherapy and at least 9 weeks of trastuzumab. 6. Breast and/or axillary surgery was completed, and postoperative pathology at the participated center confirmed the presence of invasive carcinoma in breast or axillary tissue. 7. Hormone receptor status is known. 8. The functional level of the organ must meet the following requirements: 1) Routine blood test: ANC >= 1.5*10e9/L; PLT >= 90*10e9/L; Hb >= 90g/L. 2) Blood biochemical test: TBIL = 50mL/min(Cockcroft-Gault). 3) Echocardiography: LVEF >= 50%. 9. For patients with a negative serum pregnancy test, potential fertility patients must agree to use an effective non-hormonal contraceptive method during treatment and at least 6 months after the last use of the experimental drug. 10. Participate in this study voluntarily, sign informed consent, have good compliance and are willing to cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with inflammatory breast cancer or breast cancer during pregnancy. 2. Patients with newly diagnosed metastatic breast cancer (stage IV) or with distant metastasis during and after treatment. 3. Surgical resection of the primary lesion or regional lymph node is not radical. 4. Inability to swallow, chronic diarrhea, and intestinal obstruction are factors that affect drug use and absorption. 5. Participated in any other adjuvant drug clinical study before enrollment. 6. Patients treated with pyrrolitinib at the neoadjuvant stage. 7. Previous 5 years of other malignant neoplasms, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin. 8. Known allergy to drugs or drug components used in the study. 9. A history of immunodeficiency, including HIV positive, other acquired/congenital immunodeficiency diseases, and a history of organ transplantation. 10. Has or is suffering from the following heart diseases: 1) myocardial infarction; 2) Angina; 3) Arrhythmia requiring drug treatment; 4) Any other heart disease that is judged by the researcher to be unfit to participate in this study. 11. Women who are pregnant or breastfeeding, or who are fertile and test positive for baseline pregnancy tests, or women of childbearing age who are unwilling to use effective contraception throughout the trial period. 12. Concomitant diseases (including but not limited to severe hypertension beyond the control of drugs, severe diabetes, active infections, etc.) that, in the investigator's judgment, pose a serious risk to the patient's safety or affect the completion of the study. 13. A clear history of neurological or psychiatric disorders, including epilepsy or dementia. 14. CYP3A4 inhibitor or inducer should be used for more than 28 days. 15. In the opinion of the researcher, the patient is not suitable to participate in any other condition of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| iDFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| DFS;OS;BCSS;Safety; | — |
Countries
China
Contacts
Public ContactHongwei Yang/Zhenggui Du
Suining Central Hospital/West China Hospital of Sichuan University
Outcome results
None listed