HER2-positive metastatic breast cancer
Conditions
Interventions
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Pathologically confirmed invasive breast cancer 2) ECOG performance status 0-2 3) Metastatic breast cancer or unresectable locally advanced (stage IIIB/IIIC) breast cancer 4) HER2 positive (3+ staining by immunohistochemistry [IHC] or HER2 gene amplification [HER2:CEP17 signal ratio of 2.0 or more] by FISH) confirmed in the invasive component of the primary or metastatic lesion 5) Previously treated with taxanes 6) Disease progression or distant relapse has been observed during treatment with trastuzumab-containing regimens. 7) Previously untreated with oral fluoropyrimidines including capecitabine and S-1 (Eligible if oral fluoropyrimidines other than capecitabine and S-1 are used only in neo-adjuvant or adjuvant setting) 8) Previously untreated with HER2 tyrosine kinase inhibitors 9) Previously treated with no more than two chemotherapy regimens for metastatic or unresectable locally advanced disease 10) No brain metastases or asymptomatic brain metastases 11) Subjects who have either measurable or non-measurable disease other than brain metastases 12) Able to swallow oral medications 13) Adequate baseline organ and marrow function as defined below: Absolute neutrophil count >=1.5x10^9/L Hemoglobin >=9.0 g/dL Platelets >=100x10^9/L AST and ALT <=100IU/L Serum bilirubin <=1.5 mg/dL Serum creatinine <=1.5 mg/dL 14) Baseline LVEF >= 50% by echocardiography 15) Life expectancy of at least 3 months 16) Signed written informed consent
Exclusion criteria
Exclusion criteria: 1) History of other malignancy,except for curatively treated carcinoma in situ or intramucosal carcinoma (Subjects with other malignancies who have been disease-free for at least 5 years are eligible.) 2) Active infection under treatment 3) Concurrent serious disease or condition 4) Pulmonary fibrosis or interstitial pneumonitis by chest x-ray 5) Symptomatic brain metastases or carcinomatous meningitis 6) History of serious allergic reactions 7) Concurrent continuous systemic treatment with medications listed below: Steroids Warfarin CYP3A4 inducing anticonvulsants Rifampicin Azole antifungals 8) Concurrent serious psychiatric disorder 9) Pregnant or lactating females or subjects of childbearing potential who do not agree to use adequate contraception 10) HBsAg-positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate, overall survival, proportion of subjects progressing with brain metastases as site of first progression, and safety | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed