Phase II study of weekly nanoparticle albumin-bound paclitaxel for patients with metastatic breast cancer (KSCOG-BC04)
- Conditions
- Breast Cancer
- Registration Number
- JPRN-UMIN000008861
- Lead Sponsor
- Department of Surgery, Kurume University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 55
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response Rate
- Secondary Outcome Measures
Name Time Method