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Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized,open-label,multi-center,active-controlled, parallel design study of the combination of pyrotinib and capecitabine versus Lapatinib plus capecitabine in HER2+ MBC patients, who have prior received taxane and trastuzumab.Patients will be 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 disease progression, unacceptable toxicity, or withdrawalof consent.
Enrollment
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Inclusion criteria
Aged ≥18 and ≤70 years.
ECOG performance status of 0 to 1.
Life expectancy of more than 12 weeks.
According to RECIST 1.1, at least one measurable lesion exists
Histologically or cytologic confirmed HER2 positive metastatic breast cancer.
Prior treatment with trastuzumab (≥2 cycles in metastatic setting, or
≥3 months in adjuvant/neoadjuvant setting) and Taxane(≥2 cycles in any setting or untill unendurable AE or progression during treatment).
Previously reveived ≤2 chemotherapy regimens in metastasis setting;
Required laboratory values including following parameters:
ANC: ≥ 1.5 x 10^9/L; Platelet count: ≥ 90 x 10^9/L; Hemoglobin: ≥ 90 g/L; Total bilirubin: ≤ 1.5 x upper limit of normal (ULN); ALT and AST: ≤ 2 x ULN(patients with liver metastases: ≤5 x ULN); BUN and Creatinine:
≤ 1x ULN;CCR≥50 mL/min;LVEF: ≥ 50%;QTcF: < 450 ms (male),< 470 ms(female);
Signed informed consent.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
240 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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