locally advanced / metastatic HER2-positive breast cancer
Conditions
Interventions
Administration of eribulin with a dose of 1.4mg/m2 for days 1 and 8. Administration of trastuzumab every 3 weeks or weekly with a starting dose of 8mg/kg (weekly
4mg/kg) followed by 6mg/kg (weekly
2mg/kg ) as the second and subsequent doses.
Sponsors
Nagoya University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1)Females with breast cancer which is confirmed to be invasive breast cancer by histological or cytological examination. (2)Patients with a performance status (ECOG) of 0, 1, or 2 (3)HER2(3+) by immunohistochemical or positive by fluorescence in situ hybridization methods. (4)Patients using chemo agents or trastuzumab as 1st line therapy of advanced/reccurent breast cancer. (5)Patients with a lesion allowing RECIST (ver.1.1) measurement by imaging examinations such as CT or MRI. (6)Patients with adequately maintained organ functions. (7)Patients fulfilling the following conditions within 14 days before registration. 1. Neutrophil>=1,500/mm3 2. Platelet>=100,000/mm3 3. Hb>=9.0g/dL 4. T-BIL<=2.0mg/dL 5. AST, ALT < 2.5 x ULN (Patients with liver metastases; < 5.0 x ULN) 6. Serum creatinine <= 1.5mg/dL 7. non-hematologic toxicity <= Grade2 (except for alopecia) (8)Patients expected to survive for 6 months or more. (9)Left ventricular ejection fraction (LVEF) is equal or greater than 55% measured by cardiac ultrasonography (or MUGA scan) within 28 days before registration. (10)Patients not have QTc prolongation by electrocardiogram (QTc: less than 470msec) within 28 days before registration. (11)Patients who provided written informed consent by themselves in principle to participate in this trial.
Exclusion criteria
Exclusion criteria: (1)Patients with active double cancer with less than 5years desease free intervals except for dissected carcinoma in situ or intramucosal cancer. (2)Patients with a past history of interstitial pneumonitis, pulmonary fibrosis or severe emphysema. (3)Patients diagnosed as having unstable angina, congestive heart failure, myocardial infarction, ventricular arrhythmia requiring medication within 6 months before registration. (4)Patients with uncontrolled complications(malignant hypertension,infection,hemorrhagic tendency,diabates) (5)Active infection or fever suspicious of infection (6)Severe renal dysfunction and liver dysfunction (jaundice) (7)History use of eribulin (8)Patients with uncontrollable brain metastases (9)HBs antigen positive (case of the anti-HBs or anti-HBc positive patients in HBs antigen negative, for adding precision inspection and administration of nucleic acid analog, do at the discretion of each facility) (10)Patients who were considered by the primary care physician to be inappropriate as subjects of this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate | — |
Countries
Japan
Contacts
Public ContactNobuyuki Tsunoda
Nagoya University Division of Surgical Oncology
Outcome results
None listed