Breast cancer
Conditions
Interventions
Single arm:Pyrroitinib maleate tablets combined with trastuzumab and albumin-bound paclitaxel
Sponsors
Jiangsu Provincial People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged 18 to 75 years; 2. ECOG score 0-1; 3. Expected survival not less than 12 weeks; 4. According to RECIST1.1, at least one measurable lesion exists; 5. No systematic anti-tumor treatment (except first-line endocrine therapy) was received during the recurrence/metastasis stage; 6. 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): (1) blood routine examination: neutrophils (ANC) >=1.5x10^9/L; Platelet count (PLT) >=90x10^9/L; Hemoglobin (Hb) >=90g/L; (2) blood biochemistry: total bilirubin (TBIL) =50%; 8. 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. No tyrosine kinase inhibitor (TKI) preparations or macromolecular antibodies targeting HER have been used in the new/adjuvant stage of breast cancer, except trastuzumab; 2. In the breast cancer (new) adjuvant therapy phase, the time interval from the end of systemic therapy (excluding endocrine therapy) to the detection of recurrence/metastasis is =grade 3; 4. The inestigators judged that the patients were not suitable for systemic chemotherapy; 5. Used endocrine therapy drugs within the first 7 days of randomization; 6. Other malignancies in the past 5 years, excluding cured carcinoma in situ of the cervix, basal cell carcinoma of the skin, or squamous cell carcinoma; 7. Patients with only bone as the sole target lesion; 8. Prior treatment with anthracyclines in excess of the cumulative dose; 9. Prior to screening, the patient underwent major surgical procedures or significant trauma in the first 4 weeks, or was expected to undergo major surgical treatment; 10. Severe heart disease or discomfort; 11. Inability to swallow, chronic diarrhoea, intestinal obstruction or the presence of other factors affecting the use and absorption of medicines; 12. A known history of allergy to the drug components of this regimen; 13. Have acquired, congenital immune deficiency disorder, or have a history of organ transplantation; 14. There is a third gap effusion (such as hydrothorax and ascites) that cannot be controlled by drainage or other means; 15. Pregnant or lactating female subjects, or subjects of childbearing age who are unwilling to take effective contraceptive measures during the whole study period and within 7 months after the last study; 16. Having a serious concomitant disease or other concomitant disease that interferes with planned treatment or any other condition that makes it inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR;AE; | — |
Countries
China
Contacts
Public ContactXie Hui
Jiangsu Provincial People's Hospital
Outcome results
None listed