Locally advanced breast cancer
Conditions
Interventions
Nab-paclitaxel
Sponsors
Department of Surgical Oncology, Osaka City University Graduate School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Patinets with a histopathological diagnosis of invasive breast cancer 2)Women for an initial diagnosis of IIIB or stage IIIC breast cancer 3)An age of 20 years to 70 years 4)Having at least one measureable lesion 5)HER2 status,IHC 3+ or FISH score>2.2, is comfirmed by biopsy specimen 6)Baseline left ventricular ejection fraction (LVEF) => 55% measured by echocardiography or MUGA scan. (comfirmed within 28 days before ragistration) 7)No clinical problem is found in ECG (comfirmed within 28 days before registraion) 8)ECOG performance status is 0 or 1 9)Adequate organ functions confirmed with following major examination WBC=>4000mm3 Neutrophil=>2000mm3 Platelet count=>100,000/mm3 Hemoglobin=>9.0g/dL AST,ALT=<100IU/L Total bilirubin=<1.5mg/dL Serum creatinine=<1.5mg/dL Albmin=>3.0mg/dL 10)Obtained written informed consent
Exclusion criteria
Exclusion criteria: 1)With history of hypersensitivity reaction for important medications in this treatment 2)Inflammatory breast cancer(T4d) 3)Synchronous double cancer (carcinoma in situ) which is controllable by local treatment is excluded 4)With uncontrollable infectious disease, diarrhea, ileus, diabetes, or other serious complications 5)With active pleural effusion or ascites 6)With serious heart disease, or the patient who has past history of it 7)With severe peripheral nerve disorder 8)With GI ulcer or GI hemorrhage 9)Having a past history of severe mental disorder or the patient who is under treatment of it 10)Pregnancy, or suspected pregnancy 11)HBs antigen positive or the patient for whom deoxyribonucleic acid analog is needed 12)Cases who physician judged improper to entry this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose and recommended dose in phase I study Respose rate in phase II study | — |
Countries
Japan
Contacts
Public ContactTsutomu Takashima
Osaka Breast Cancer Chemo-Endocrine Therapy Study Group Executive office
Outcome results
None listed