Breast Cancer
Conditions
Interventions
experimental group:Pyrotinib + Trastuzumab + Taxanes
control group:Trastuzumab + Pertuzumab + Taxanes
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years and = 12 months; 6. ECOG performance status 0-1; 7. Adequate organ function levels: Hematology Absolute neutrophil count (ANC) >= 1.5 × 10?/L (without use of hematopoietic growth factors within 14 days prior to first dose of study treatment); White blood cell count (WBC) >= 3.0 × 10?/L and = 100 × 10?/L (without blood transfusion within 14 days prior to first dose of study treatment); Hemoglobin (Hb) >= 90 g/L; Blood biochemistry Total bilirubin (TBIL) = 50 mL/min (Cockcroft-Gault formula); Cardiac function Echocardiography: LVEF >= 50%; 12-lead ECG: QT interval < 470 ms for females. 8. Brain metastases previously treated with local therapy may be stable since treatment or may have progressed since prior local therapy for central nervous system (CNS) disease, provided there is no clinical indication for immediate repeat local treatment. For participants who undergo local therapy for newly detected or previously treated and progressing CNS lesions, enrollment may be possible if all the following criteria are met: At least 7 days after stereotactic radiosurgery (SRS), at least 14 days after whole-brain radiotherapy (WBRT), or at least 28 days after surgical resection prior to the first dose of study treatment. 9. Patients must voluntarily participate and sign the informed consent form, with anticipated good compliance and ability to cooperate with the study protocol; 10. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and voluntarily agree to use adequate contraception during the observation period and for 7 months after the last dose of study treatment.
Exclusion criteria
Exclusion criteria: 1. Patients who had SD/PD during neoadjuvant HP/H therapy; 2. Patients who received TKI therapy during prior adjuvant therapy; patients who had SD/PD after TKI therapy during neoadjuvant therapy; 3. Concurrent receipt of any other anti-tumor therapy; 4. Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer; 5. Breast cancer without histopathological confirmation; 6. Active brain metastases or leptomeningeal metastases; 7. History of other malignancies within the past 5 years, except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the cervix; 8. Severe dysfunction of vital organs such as the heart, liver, or kidneys; 9. Inability to swallow, chronic diarrhea, or intestinal obstruction, or presence of multiple factors affecting drug administration and absorption; 10. Participation in other drug clinical trials within 4 weeks prior to enrollment; 11. Known history of allergy to any component of the study drugs; 12. History of immunodeficiency diseases, including positive HIV test, HCV, active hepatitis B virus infection, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation; 13. Any cardiac disease within 6 months prior to signing informed consent, including: a.Arrhythmias requiring medication or clinically significant arrhythmias; b.Myocardial infarction; c.Heart failure; d.Any other cardiac disease judged by the investigator as unsuitable for participation in this trial; 14. Pregnant or lactating women, women of childbearing potential with a positive baseline pregnancy test, or women of childbearing potential unwilling to use effective contraception throughout the trial period; 15. According to the investigator's judgment, the presence of concomitant diseases that pose a serious risk to patient safety or could affect the patient's ability to complete the study (including but not limited to severe hypertension uncontrollable by medication, severe diabetes, active infections, etc.); 16. Documented history of neurological or psychiatric disorders, including epilepsy or dementia; 17. Any other circumstances under which the investigator deems the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;objective response rate, ORR;Duration of relief, DoR;Safety; | — |
Countries
China
Contacts
Public ContactPan Yueyin
Anhui Provincial Cancer Hospital
Outcome results
None listed