breast cancer
Conditions
Interventions
Experimental group:pyrotinib combined with treatment of physicians choice (TPC)
Control group:TPC
Sponsors
Chongqing Key Laboratory of Translational Research for Cancer Metastasis and Individualized Treatment, Chongqing University Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Signed Informed Consent Form(ICF); (2) Women aged 18 to 75 years; (3) Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1; (4) Expected survival more than 12 weeks; (5) Histologically or cytologically confirmed invasive breast cancer, including locally advanced breast cancer (stage IIIb, stage IIIc) or recurrent and metastatic breast cancer; (6) HER2 positive confirmed by our laboratory tests (HER2 positive definition: IHC 3+ or FISH +); (7) At least one measurable lesion according to RECIST version 1.1 criteria; (8) Disease progress after or during trastuzumab treatment: receive continuous trastuzumab = 2 cycles during relapse/metastasis; or continuous use of trastuzumab = 3 months during adjuvant therapy; (9) Adequate organ function within 7 days prior to the first study treatment: 1) Neutrophil (ANC) >= 1.5x10^9/L, platelet count (PLT) >= 90x10^9/L, hemoglobin >=90 g/L; 2) Serum total bilirubin (TBIL) = 50% by ECHO; 4) The QT interval (QTcF) corrected by the Fridericia method is <470 msec.
Exclusion criteria
Exclusion criteria: (1) Complicated with brain metastasis or nervous system oppression; (2) Used of HER2-targeted tyrosine kinase inhibitors (including lapatinib, pyrotinib and neratinib et.) (3) A third space effusion (e.g. pleural effusion and ascites) that cannot be controlled by drainage or other means. (4) Inability to swallow, intestinal obstruction or other factors affecting drug use and absorption; (5) Cannot tolerate systemic chemotherapy; (6) Known allergy to any components of the drug; (7) Known history of immunodeficiency, including HIV positive testing, or other acquired, congenital immunodeficiency disorders, or organ transplantation history; (8) Other malignant tumors in the past five years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma; (9) Pregnant or lactating, or those with fertility and positive baseline pregnancy test, or those of childbearing age who are unwilling to take effective contraceptive measures throughout the trial; (10) The patient has a serious concomitant disease, or the researcher thinks that the patient is not suitable to participate in any other situation of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;duration of response;disease control rate;overall survival;safety; | — |
Countries
China
Contacts
Public ContactXiaohua Zeng
Chongqing Key Laboratory of Translational Research for Cancer Metastasis and Individualized Treatment,Chongqing University Cancer Hospital
Outcome results
None listed