Breast Cancer
Conditions
Interventions
Nab-paclitaxel 100mg/m2 on days 1, 8, 15 <
HER2 positive>
Nab-paclitaxel 100mg/m2 on days 1, 8, 15 Trastuzumab* : 2mg/kg , Day 1, 8, 15, 22 *4 mg/kg for the initial dosing (day 1) Cycles are repeated every 4 weeks.
Sponsors
Department of Surgery, Kurume University School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Written informed consent to participate 2) Suitable judgement by physician 3) Histological and/or cytological confirmed breast cancer 4) Metastatic breast cancer 5) The below criteria are met about prior therapy a. chemotherapy: more than 14 days passed after prior chemotherapy. b. hormonal therapy: more than 7 days passed after hormonal therapy c. radiation: more than 14 days passed after radiation. 6) Age 20 or over 7) Performance status (ECOG) 0-2 8) Has measurable lesion with CT within 28 days according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 9) The below criteria met within 14 days prior to therapy 1.WBC between 3,000/mm3 and 12,000/mm3 2.Granulocyte count 1,500/mm3 or over 3.Platelet count 100,000/mm3 or over 4.Hb 9.0 g/dl or over 5.Total bilirubin 2.0 mg/dL or under 6.AST(GOT) 100 IU/L or under 7.ALT(GPT) 100 IU/L or under 8.Serum creatinine 1.5 mg/dl or under 9.(only HER2 positive) Left ventricle ejection fraction 55 % or over by cardiac sonography or MUGA scan 10) Expected survival longer than 3 months
Exclusion criteria
Exclusion criteria: 1) Anamnesis of hypersensitivity to drugs(especially paclitaxel or albumin) 2) Ttreatment history of taxanes (paclitaxel or docetaxel) for metastatic breast cancer 3)Peripheral neuropathy Grade2 or over 4) Pregnancy, or suspected pregnancy 5)Severe Infection (38 degrees or over) 6)Severe complication (interstitial pneumonia or pulmonary fibrosis, renal failure, hepatic failure, uncontrolled diabetes, uncontrolled hypertension and so on) 7) ECG abnormalities 8)Heart failure with clinically problem (cardiac failure, cardiac infarction, angina, cardiac valvulopathy) 9) Active secondary malignancy within 5 years of disease free interval(but, registerable for cured cutaneous basal cell carcinomas and cervical cancer, cured gastric cancer, esophageal cancer and pm-colorectal cancer by endoscopic mucosal resection) 10)Pleural effusion, ascites, and pericardial effusion that need treat 11) Symptomatic brain metastasis 12)Consecutive systemic administration of steroids 13)Physician judged improper to entry this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | — |
Countries
Japan
Contacts
Public ContactToh Uhi
Kurume University School Department of Surgery
Outcome results
None listed