Breast Cancer
Conditions
Interventions
experimental group:Combination of Pyrrotini and Yew/vinorelbine
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female, aged >= 18 years old and = 1.5 x 10^9/L PLT >= 100 x 10^9/L Hb >= 90 g/L (2) Blood biochemistry TBIL = 50 ml /min (Cockcroft Gault formula); (3) Color Doppler echocardiography: LVEF >= 50%; (4) 12 lead ECG The QT interval (QTCF) corrected by fridericia method was < 480 MS in females. 11. The subjects who voluntarily joined the study signed informed consent, had good compliance and were willing to cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with meningeal and / or spinal cord metastasis; 2. There are many factors that affect the taking and absorption of drugs in patients with dysphagia, chronic diarrhea and intestinal obstruction; 3. Patients with effusion in the third space that cannot be controlled by drainage or other methods (such as large amount of pleural effusion and ascites); 4. Patients who received any anti-tumor treatment for any other tumor at the same time; 5. Patients with other malignant tumors in the past five years, excluding cured cervical carcinoma in situ, basal cell carcinoma of skin or squamous cell carcinoma of skin; 6. Patients who received radiotherapy and surgery within 4 weeks before enrollment (excluding local puncture); patients who received anti-tumor endocrine therapy after entering the screening period; patients who received anti-tumor endocrine therapy after entering the screening period; 7. Patients who have used or are using tyrosine kinase inhibitors targeting HER2 (lapatinib, lenatinib, pyrrolotinib, etc.) or ADC drugs against HER2 (t-dm1, etc.); 8. Patients with any heart disease, include: (1) Arrhythmias requiring drug treatment or of clinical significance; (2) Myocardial infarction; (3) Heart failure; (4) Any other heart disease judged by the researcher not suitable for participating in this trial; 9. Patients with known history of allergy to the drug components of this protocol; history of immunodeficiency, including HIV positive, active hepatitis B / C or other acquired or congenital immunodeficiency diseases, or history of organ transplantation; 10. Patients with a clear history of neurological or mental disorders, including epilepsy or dementia; 11. Pregnant and lactating women, women with fertility and positive baseline pregnancy test, or women of childbearing age who are not willing to take effective contraceptive measures during the whole trial period; 12. According to the judgment of the researchers, patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study (including but not limited to severe hypertension, severe diabetes, etc. that cannot be controlled by drugs, etc.); 13. The researchers believe that the patients is not suitable for any other situation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;CBR;DoR;OS; | — |
Countries
China
Contacts
Public ContactJifeng Feng
Jiangsu Cancer Hospital
Outcome results
None listed