A multicenter study of adjuvant nab-paclitaxel followed by FEC for early breast cancer
Phase 2
- Conditions
- Primary breast cancer
- Registration Number
- JPRN-UMIN000029836
- Lead Sponsor
- Kyushu Breast Cancer Study Group (KBC-SG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with a history of hypersensitivity to paclitaxel and/or albumin 2) Metachronous bilateral breast cancer 3) Inflammatory breast cancer 4) Active double cancer 5) Other severe complications such as infectious diseases, diarrhea, intestinal palsy, intestinal obstruction, uncontrolled diabetes mellitus, uncontrolled angina, myocardial infarction within 6 months and heart failure 6) Pregnant and nursing female 7) Patients with pulmonary fibrosis or interstitial pneumonia 8) Sever bone marrow suppression, renal dysfunction, liver dysfunction 9) History of hypersensitivity reaction 10)Others
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method completion rate of treatment
- Secondary Outcome Measures
Name Time Method safety, disease free survival, period until the onset of peripheral neuropathy and period to recovery, QOL related to peripheral neuropathy