breast cancer
Conditions
Interventions
experimental group:Pyrotinib 400mg po qd/q21d + trastuzumab First dose 8mg/kg, followed by 6mg/kg ivgtt d1/q21d + any of the following chemotherapy drugs (capecitabine 1000/m2 po bid d1-14/q21d, Gemci
Sponsors
Department of Breast Medicine, Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Non-pregnant women aged 18 or older; 2. Advanced or metastatic breast cancer, her-2 positive, positive criteria: FISH method to detect HER-2 gene amplification or immunohistochemical HER-2 3+; 3. Advanced breast cancer, previous neoadjuvant or adjuvant with or without trastuzumab, lapatinib, pertuzumab, T-DM1, lenatinib; 4. Target or non-target lesions according to RECIST 1.1; 5. The drug toxicity caused by the last systematic treatment should be reduced to Level 1 or level 0. Special case: Hair loss grade neuropathy return to grade 2 or less. Class I congestive heart failure due to the last treatment should be fully recovered before treatment can begin; 6. ECOG PS score is 0 or 1 7. The expected survival time is no less than 3 months; 8. Normal hematopoietic function of bone marrow, no bleeding tendency (INR= 90g/L, WBC > 3.0 x 10^9/L (NEU >= 1.5 x 10^9/L), PLT >= 80 x 10^9/L; 9. Liver function: total bilirubin = 60mL/min. 11. No other serious heart and lung diseases; 12. Informed consent of the patient or authorized client and written informed consent signed.
Exclusion criteria
Exclusion criteria: 1. Patients with cognitive dysfunction or poor treatment compliance determined by researchers; (b) those deemed unsuitable for clinical trials by the investigator; 2. 14 days prior or 5 half-life prior treatment with another study drug; 3. The date of last trastuzumab or other monoclonal antibody treatment was less than 3 weeks, or chemotherapy or hormone therapy was received 2 weeks prior to the start of treatment; 4. Prior cumulative doxorubicin dose > 360mg/m2, or prior cumulative doxorubicin dose >360mg/m2 with any other anthracycline; 5. Previous treatment history: Patients who had received corresponding chemotherapy drugs during neoadjuvant or adjuvant therapy, and whose withdrawal time was longer than 1 year, could be included in the analysis; 6. Diseases of the central nervous system: Patients with flexural meningeal metastasis were excluded from the study; Patients with symptomatic BMS were excluded from the study; Patients with treatable or untreated asymptomatic BMS who do not require immediate local treatment may be included in the study. 7. Patients allergic to small molecule HER-2 inhibitors or corresponding chemotherapy drugs or trastuzumab were not included in the study; 8. Dysphagia, unable to swallow pyrrolitinib or corresponding chemotherapy drugs, or patients with digestive diseases, affecting the absorption of oral drugs; 9. CYP3A4YI inhibitors or inducers were taken during the three drug half-life periods before the study began; 10. CYP2C8 inhibitors or inducers were taken during the three drug half-life periods before the study began; 11. Receive radiotherapy within 14 days prior to first administration of pyrrotinib. If patients who had received radiotherapy were included, the acute response to radiotherapy should have returned to baseline level before treatment began; 12. Known cardiac insufficiency or heart disease with clinically obvious symptoms, such as ventricular arrhythmias, requiring treatment; Congestive heart failure, refractory hypertension (defined as systolic blood pressure greater than 150mmHg and/or diastolic blood pressure greater than 100mmHg with any antihypertensive medication); Had a myocardial infarction or unstable angina 6 months ago; 13. Incomplete dihydropyrimidine or dehydrogenase function; 14. The patient was treated with warfarin but could not be regularly tested for INR or INR was no longer within the range required. Patients receiving warfarin and INR within treatment requirements may be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;disease control rate;clinical benefit rate;Adverse effect; | — |
Countries
China
Contacts
Public ContactCaiwen Du
Department of Breast Medicine, Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed