Advanced or recurrent HER2-positive breast cancer
Conditions
Interventions
Administration of eribulin, pertuzumab and trastuzumab every three weeks until disease progression or occurring adverse events difficult to continue.
Sponsors
SONG (South Osaka Network Group for Breast Cancer)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed invasive breast cancer 2. Second line or later therapy of Stage IIIB,IIIC,IV or advanced / recurrent breast cancer previously treated with anti-HER2 therapy 3. HER2 positive as determined by score of 3+ on IHC staining or gene amplification by FISH 4. Previous treatment with anthracyclines or taxanes 5. ECOG performance status(PS) 0-2 6. Adequate organ function shown in laboratory measurements within 14 days prior to enrollment Neutrophil count >=1500/mm3 Platelet count >=75,000/mm3 Hemoglobin >=8.0g/dL Total serum bilirubin <=2.0mg/dL AST and ALT <100IU/L Serum creatinine <=1.5mg/dL 7. Echocardiographic ejection fraction >=50% 8. Written informed consent for study entry
Exclusion criteria
Exclusion criteria: 1. History of drug allergies with eribulin or pertuzumab or trastuzumab 2. Pregnant females or females of child-bearing potential2 3. Serious cardiac disorder 4. Not suitable for participation with any other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate (RR), Safety | — |
Countries
Japan
Contacts
Public ContactHajime Abe
Bell Land General Hospital Breast Center
Outcome results
None listed