Breast Cancer
Conditions
Interventions
experimental group:Anlotinib+pyrotinib+capecitabine
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, female; 2. Patients with recurrent/metastatic breast cancer confirmed by pathological examination with positive HER2 expression; Positive expression of HER2 refers to those whose HER2 is positive by standard immunohistochemical staining (IHC) and/or fluorescence in situ hybridization (FISH) (verified by the researchers in the test center); 3. According to RECIST1.1, at least one measurable lesion exists; 4. Life expectancy of more than 12 weeks 5. ECOG performance status of 0 to 1 6. Prior treatment with trastuzumab (>=2 cycles in metastatic setting, or>=3 months in adjuvant/neoadjuvant setting) Taxane(>=2 cycles in any setting or untill unendurable AE or progression during treatment) 7. Previously reveived = 1.5 x 10^9/L; b. Platelets(PLT)>= 100 x 10^9/L; c. Hemoglobin(HB)>= 90g / L; (2) blood biochemistry: a. Total bilirubin(TBIL)1.0 ULN but direct bilirubin = 60mL / min; 9. Voluntarily joined the study, signed the informed consent, had good compliance and was willing to cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with clinical symptomwho need to be treated; 2. Received capecitabine in metastatic setting; 3. Received chemotherapy, target therapy or other research drugs within 28 days prior to enrollment. Received hormone therapy within 7 days prior to enrollment; 4. Received HER2 targeted tyrosine kinase inhibitor (including Lapatinib, Neratinib and Pyrotinib); 5. Uncontrolled pleural effusion, pericardial effusion and peritoneal effusion requiring repeated drainage; 6. several factors ,such as unable to swallow, chronic diarrhea and intestinal obstruction; 7. Was allergic to the study drug or any of its excipients, including HIV positive, or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; 8. Second malignancies within 5 years, except for cured skin basal cell carcinoma,carcinoma in-situ of uterine cervix and squamous-cell carcinoma; 9. Female patients during pregnancylactation or were positive after baseline pregnancy test, women of childbearing age who are unwilling to take effective contraceptive measures during the whole trial period and within 7 months after the last study medication; 10. Patients whose blood pressure control is not ideal (systolic pressure >= 150 mmHg, diastolic pressure >= 100 mmHg), or urine routine indicated urinary protein >= ++, and confirmed 24-hour quantitative urinary protein > 1.0g; 11. Patients whose tumors have invaded around important blood vessels according to imaging findings or whose tumors are likely to invade important blood vessels or whose tumors are obviously necrotic and cause fatal massive hemorrhage according to the judgment of the researchers during the follow-up study; 12. Patient has experienced A number of thrombosis events, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism within 6 months; 13. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months; 14. Regardless of the severity, patients with any physical signs or history of bleeding, patients with bleeding or bleeding events greater than or equal to CTCAE 3 within four weeks prior to the first administration, or patients with unhealed wounds, fractures, gastric and duodenal active ulcers, ulcerative colitis, or unresected tumors have active bleeding, or may be caused as determined by the researchers. Other conditions of gastrointestinal bleeding and perforation; 15. Have concomitant or other disorder diseases that may interfere with planned treatment, or any other condition that the investigator believes is not suitable for the study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival time(PFS);Objective response rate(ORR);Clinical benefit rate(CBR);Objective duration of relief(DoR);Lifetime(OS);Safety; | — |
Countries
China
Contacts
Public ContactLuo Ting
West China Hospital of Sichuan University
Outcome results
None listed