breast cancer
Conditions
Interventions
Group A:trastuzumab+pyrotinib+dalpiciclib+/-letrozole
Sponsors
Xiangya Hospital, Central South University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged 18-70 years; 2. All patients were breast cancer with positive HER2 expression confirmed by histopathology; 3. Breast cancer meets the following criteria: (1) For histologically confirmed invasive breast cancer, the diameter of the primary tumor measured by the standard evaluation method of the research center is > 2 cm; (2) Tumor stage: early stage (T2-3, n0-1, M0) or local late stage (T2-3, N2 or N3, M0); 4. The patient is resistant or intolerant to chemotherapy; 5. KPS score >= 70; 6. The functional level of organs is basically normal: bone marrow function, liver and kidney function, heart; 7. Be able to accept puncture biopsy; 8. Voluntarily join the study, sign informed consent, have good compliance and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Previously received any form of anti-tumor treatment (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.); 2. Receive any other anti-tumor treatment at the same time; 3. Bilateral breast cancer, inflammatory breast cancer or occult breast cancer; 4. Other malignant tumors occurred in the past 5 years, except for the cured carcinoma in situ of the cervix; 5. Inability to swallow, chronic diarrhea and intestinal obstruction, and there are many factors affecting drug administration and absorption; 6. Participated in clinical trials of other drugs within 4 weeks before enrollment; 7. Those who are known to have a history of allergy to the drug components of this protocol; 8. Have a history of immunodeficiency, including HIV positive, HCV, active hepatitis B or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 9. Have suffered from any heart disease, including: (1) arrhythmia requiring drug treatment or clinically significant; (2) Myocardial infarction; (3) Heart failure; (4) Any other heart disease judged by the researcher as unsuitable for the test; 10. Female patients during pregnancy and lactation, female patients with fertility and positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures during the whole test period; 11. According to the judgment of the researcher, 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, severe diabetes, active infection, etc. beyond the control of drugs); 12. Have a clear history of neurological or mental disorders, including epilepsy or dementia; 13. The investigator considers that the patient is not suitable for any other circumstances in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Ki67; | — |
Countries
China
Contacts
Public ContactShouman Wang, Zhi Xiao
Xiangya Hospital, Central South University
Outcome results
None listed