HER2 positive metastatic breast cancer
Conditions
Interventions
Combination of Eribulin with Trastuzumab.
Sponsors
Setouchi Breast Project
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed invasive breast cancer in biopsy specimens obtained from the tumor. 2.Presense of overexpression of HER2 in the tumor examined. 3.At least one measurable metastatic lesion other than the breast tumor and axillary lymph nodes detected by CT or MRI before primary registration. 4.ECOG performance status (PS) 0,1,2 5.No surgery, chemotherapy or radiotherapy for any other malignancies within the previous 3 weeks. 6.Adequate organ functions. 7.Availability of written informed consent.
Exclusion criteria
Exclusion criteria: 1. Simultaneous or metachronous (within 5 years) double cancers. 2.Pregnant or breast-feeding women. 3. Psychiatric diseases. 4. Systemic and continuous steroid treatment. 5. with symptomatic brain metastasis 6. Uncontrolled hypertension. 7. Uncontrolled diabetes mellitus or the disease being treated by continuous insulin administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, Overall survival, Safety | — |
Countries
Japan
Contacts
Public ContactTadahiko Shien
Setouchi Breast Project Clinical trial committee
Outcome results
None listed