HER2-positive locally advanced or metastatic breast cancer
Conditions
Interventions
Trastuzumab + chemotherapy Chemotherapy regimen is chosen from the following
Docetaxel,Paclitaxel, nab-paclitaxel, vinorelbine, Eribulin, Capecitabine or Gemcitabine
Trastuzumab+ pertuzumab + chemotherapy Chemotherapy regimen is chosen from the following
Docetaxel, Paclitaxel, nab-paclitaxel, vinorelbine, Eribulin, Capecitabine or Gemcitabine
Sponsors
Japan Breast Cancer Research Group (JBCRG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Histologically or cytologically confirmed invasive breast cancer 2.A confirmed HER2-positive status assessed by means of immunohistochemical analysis(with 3+ indicating positive status)and/or in situ hybridization(with an amplification ratio>=2.0 indicating positive) by each institute 3.History of pertuzumab and trastuzumab-containing chemotherapy for locally advanced and metastatic breast cancer(2 or 3 regimen as previous chemotherapy regimen for locally advanced or metastatic breast cancer). The latest regimen before enrollment dose not include pertuzumab. 4.Patients have measurable and/or non-measurable disease according to RECIST ver1.1. 5.Female patients and aged >= 20 years. 6.Left Ventricular Ejection Fraction (LVEF) >= 50% at baseline (within 28 days before enrollment) as determined by either ECHO or MUGA 7. Eastern Cooperative Oncology Group performance status of 0,1 or 2. 8.Life expectancy of patients is expected at least 3 months. 9.Signed and written informed consent (approved by the Institutional Review Board or Independent Ethics Committee) is obtained before any study procedure.
Exclusion criteria
Exclusion criteria: 1. Pts with >= 4 regimens of anticancer therapy for locally advanced/metastatic BC 2. Pts with non-hematologic toxicity of >= Grade 3 at enrollment 3. Pts with metastases to the central nervous system which are symptomatic or whose symptoms are difficult to be controlled 4. Pts with active multiple malignancy 5. Pts with the history of administration of any of the following cumulative doses of ATCs: Doxorubicin > 360 mg/m2 Epirubicin > 720 mg/m2 Mitoxantrone > 100 mg/m2 If patients have been treated with 2 or more ATCs, the cumulative dose should not exceed 360 mg/m2 equivalent of doxorubicin 6. Pts with uncontrolled hypertensionor unstable angina 7. Congestive heart failure that meets the NYHA classification of 2 or higher, or clinically significant arrhythmia that requires TRT 8. Pts with a history of myocardial infarction w/in 6 mos before enrollment 9. Pts with dyspnea at rest due to complications of advanced malignant tumor 10. The test results w/in 28 days before enrollment show the organ dysfunction 11. Pts with severe uncontrolled systemic disease 12. Pts with paraneoplastic hypercalcemia that cannot be controlled with bisphosphonates or denosumab 13. Pts with > Grade 2 toxicity associated with radiotherapy for BC w/in 14 days before enrollment 14. Pts who are expected to need major surgery or major trauma w/in 28 days before enrollment or major surgery during the TRT 15. Women who are pregnant or positive in pregnancy test 16. Women who are lactating 17. Pts who received the study drug w/in 28 days before enrollment 18. Pts with active systemic infection or HIV infection 19. Pts who received IV antibiotics for infection w/in 14 days before enrollment 20. Pts who receives daily TRT with IV or oral administration of corticosteroids for long time over 3 mos 21. Pts with hypersensitivity to pertuzumab, trastuzumab, and chemotherapy to be used in combination in this study 22. Pts who are unable or unwilling to comply with the requirements of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (assessed by investigators) | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS (assessed by independent review), PFS in patients treated with trastuzumab emtansine (T-DM1) as the latest regimen, Response rate, Duration of response, Overall survival (OS), Patient-reported-outcome (QOL), Safety, biomarkers | — |
Countries
Japan
Contacts
Public ContactJun Fukase
Japan Breast Cancer Research Group (JBCRG) Head office
Outcome results
None listed