Metastatic breast cancer
Conditions
Interventions
Combination treatment of gemcitabine and trastuzumab gemcitabine 1250mg/m2 day1,8 21days cycle trastuzumab 2mg/kg (Initial dose 4mg/kg) q1w continuing treatment until disease progression
Sponsors
Setouchi Breast Project Comprehensive Organization
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Signed written informed consent 2) Age over 20 years. 3) ECOG performance Status 0-2 4) Histologically confirmed adenocarcinoma of the breast 5) HER2-positive in the tissue of primary breast cancer or metastatic sites. 6) Patients must have measurable disease that is evaluable according to RECIST 1.1 7) LVEF over 50% at baseline 8) Adequate organ function 9) Prior combination treatment with trastuzumab and chemotherapy 10) Expectation of more than 3 months survival
Exclusion criteria
Exclusion criteria: 1) Active double cancer 2) Brain metastases that requiring treatment at registration 3) Unstable angina pectoris, congestive heart failure, myocardial infarction, or ventricular arrhythmia requiring medication within 6 months to registration 4) Uncontrolled hypertension or diabetes mellitus. 5) Active infection disease 6) Other severe, uncontrolled systemic disease 7) Over grade 3 hypersensitivity reaction to trastuzumab 8) Hormonal therapy, chemotherapy, or biological treatment <7days prior to registration 9) Radiation therapy <14days prior to registration 10) Prior gemcitabine therapy 11) Current pregnancy and lactation 12) Assessment by the investigator to be unsuitable to comply with the requirements of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, Overall survival, Adverse events rate | — |
Countries
Japan
Contacts
Public ContactNaruto Taira
Setouchi Breast Project Comprehensive Organization Clinical Research Group
Outcome results
None listed