Breast Cancer
Conditions
Interventions
Sponsors
Hiroshima Breast Cancer Study Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.histologically or cytologically confirmed locally advanced breast cancer or metastatic breast cancer 2.HER2 negative 3.over 20 years old, under 75 years old 4.ECOG performance status--0 or 1 5.All Pts are 1:after receiving anthracycline containing regimen for neoadjuvant and adjuvant setting, but no prior chemotherapy for metastatic disease including taxanes must have been completed more than 12 months before registering in this study 2:after receiving one regimen for locally advanced breast cancer including taxanes must have been completed more than 12 months before registering in this study 6.Patients who have passed the following periods from previous treatment 1:immunotherapy/endocrinetherapy 14 days from the final administration, in case of LH-RH analogue, 28 days are needed 2:chemotherapy 28 days 3:radiation therapy 28 days 4:operation 7 days
Exclusion criteria
Exclusion criteria: *Her2 positive *Prior administration of gemcitabine *Pulmonary fibrosis or pneumonitis *Abnormal cardiac function, myocardial infarction within 6 months *Body cavity fluid which needs to treatment *Active infection *Severe complicated situation *Severe drug allergic reaction *Serious psychiatric illness *After bone marrow transplantation *After stem cell transplantation *Symptomatic systemic brain metastasis *Active double cancer *Double chemotherapy *Pregnancy, breast feeding, suspected pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine maximum tolerated dose and recommended dose | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse events time to progression | — |
Countries
Japan
Contacts
Public ContactShigeru Murakami
Hiroshima Breast Cancer Study Group Hiroshima Cancer Support
Outcome results
None listed