Breast Cancer
Conditions
Interventions
None listed
Sponsors
Saitama Breast Cancer Clinical Study Group(SBCCSG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Patient is histologically or cytologically confirmed as locally advanced or metastatic breast cancer. 2)Patient who had relapsed after receiving anthracycline-based chemotherapy regimen. Taxanes must have been completed more than 6 months. 3)Patient who have passed the following periods from previous treatment completion date: A.Immunotherapy/endocrinotherapy; at least 14 days from the final administration date (Slow-release formulations of LH-RH agonist needs at least 28 days). B.Chemotherapy; at least 28 days from the final administration date. C.Radiotherapy; at least 28 days from the final treatment date. D.Treatment with antibodies; at least 28 days from the final administration date. 4)Patient has received radiation to not more than 20% of the bone marrow area. 5)There is no regulation concerning the hormonal therapy. 6)Performance status (PS) 0-1. 7)Patient has adequate organ functions confirmed with following major examinations conducted within 14 days before each patient's registration. 8)Patient has given written informed consent.
Exclusion criteria
Exclusion criteria: 1)Patient had received gemcitabine treatment in the past. 2)Patient with inflammatory carcinoma. 3)Patient apparently or possibly has pulmonary fibrosis or pneumonia. 4)Patient is class III or IV of NYHA functional classification or patient has cardiac infarction occurred within past six months. 5)Patient has body cavity fluid which needs to be treated. 6)Patient has active infection. 7)Patient has serious coexisting illness (including diabetes which is difficult to control). 8)Patient has serious drug allergy. 9)Patient has serious psychiatric illness that can make his/her decisions unstable or uncertain. 10)Patient had had bone marrow transplantation or stem cell transplantation. 11)Patient has symptomatic brain metastasis. 12)Patient receives continuous whole-body administration of steroid drugs (orally or intravenously.) 13)Patient has active double cancer. 14)Patient is apparently/possibly during pregnancy, lactation expectant, or desiring future fertility in the period from informed consent day to 3 months after final test drug administration. 15)Patient has received unapproved drugs or other investigational drugs within 30 days before the registration date. 16)Patient is judged unsuitable as object of this clinical trial by the principal investigator or the physician in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The optimal dosage is eventually decided by the frequency of dose limiting toxicities at the first course in each dose level. | — |
Countries
Japan
Contacts
Public ContactToshihiro Kai
Saitama Breast Cancer Clinical Study Group (SBCCSG) Secretariat Division (Shintoshin Ladies' MammoClinic)
Outcome results
None listed