metastatic or recurrent breast cancer
Conditions
Interventions
Patients receive 180mg of abraxane per squarer meter of body-surface area on day1 of every 21-day cycle The patients continue therapy until disease progression or prohibitive toxic effects occur.
Sponsors
Department of Digestive Surgery and Surgical Oncology,Yamaguchi University Graduate School of medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Histologically confirmed metastatic breast cancer Inoperative metastatic or recurrent breast cancer Age from 20 to 65 years old: Prior treatment by chemotherapy (however, age from 65 to 75 years old No previous treatment by chemotherapy is acceptable) Performance status is 0,1,2. The patient must have no carry-over of efficacy from any previous treatment Surgery 4 weeks radiation therapy: 2 weeks endocrine therapy 2weeks chemotherapy 4 weeks Required baseline laboratory data. (within 14 days of registration) WBC 3,000mm3 Neu 1,500mm3 PLT100,000 mm3 Hb 9.0 gdL ALT and AST ULN2.5 ALT and AST ULN2.5 T-Bil 1.5mgdL serum creatine 1.5mgdL Expected survival time more than 3 months The patient has personally given written, informed consent to participate in this study
Exclusion criteria
Exclusion criteria: With history of hypersensitivity reaction for paclitaxel and/or Albumin . With serious drug allergy With infectious disease With Pregnant or nursing women With ECG abnormalities or heart failure with clinically problem With Poorly controlled diabetes With active another cancer With widespread liver metastases or pulmonary lymphangitis with dyspnea With brain metastasis with symptom With dyspnea at rest (due to metastatic lung lesion and cardiovascular disease) With pleural effusion, ascites, and pericardial effusion that need treat Radiation therapy for chest With Peripheral neuropathy greater than grade 2 With pulmonary fibrosis or pneumonitis Cases who physician judged improper to entry this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of at least six treatment cycles of tri-weekly low dose Abraxane | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival,Response rate, Toxicity | — |
Countries
Japan
Contacts
Public ContactShigeru Yamamoto
Yamaguchi University Graduate School of medicine Digestive Surgery and Surgical Oncology
Outcome results
None listed