HER2 Positive Metastatic Breast Cancer
Conditions
Brief summary
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of pyrotinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have prior received anthracyclin, taxane or trastuzumab. Patients will be stratified by weather have prior use of trastuzumab and randomized in a 1:1 ratio to one of the following treatment arms: * Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m\^2 twice daily) * Arm B: lapatinib (1250 mg once daily) + capecitabine (1000 mg/m\^2 twice daily) Patients will receive either arm of therapy until the occurrence of death, disease progression, unacceptable toxicity, or other specified withdrawal criterion.
Interventions
DRUGpyrotinib
DRUGLapatinib
DRUGcapecitabine
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged ≥18 and ≤70 years. * ECOG performance status of 0 to 1. * Life expectancy of more than 12 weeks. * At least one measurable lesion exists.(RECIST 1.1). * Histologically or cytologic confirmed HER2 positive advanced breast cancer which failed prior therapies. * Required laboratory values including following parameters: ANC: ≥ 1.5 x 10\^9/L;Platelet count: ≥ 100 x 10\^9/L;Hemoglobin: ≥ 9.0 g/dL;Total bilirubin: ≤ 1.5 x upper limit of normal (ULN);ALT and AST: ≤ 1.5 x ULN;BUN and creatine clearance rate: ≥ 50 mL/min;LVEF: ≥ 50%;QTcF: \< 470 ms for female and \< 450 ms for male. * Signed informed consent
Exclusion criteria
* Received previous therapy with lapatinib, neratinib, pyrotinib or any other HER2 directe tyrosine kinase inhibitor. * Received previous therapy with capecitabine within 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety(adverse Events [AEs] and Serious Adverse Events [SAEs]) | : From consent through 28 days following treatment completion (estimated 18 months) |
| Objective Response Rate (ORR) | Estimated 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) | Estimated 18 months |
| Time to Progression (TTP) | Estimated 18 months |
| Duration of Response (DOR) | Estimated 18 months |
Countries
China
Outcome results
None listed