A Phase II study of Neoadjuvant chemotherapy in Tri-weekly nab-Paclitaxel followed by FEC with Operable HER2 Negative breast cancer
- Conditions
- HER2 negative operable breast cancer
- Registration Number
- JPRN-UMIN000008085
- Lead Sponsor
- Kinki Breast Cancer Study Group-Translational Research (KBCSG-TR)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 60
Not provided
1)Hypersensitivity to any agents necessary in the planned treatment. 2)Poorly controlled complication. 3)Active infectious disease or Fever with suspected infection. 4)Symptoms of varicella. 5)Serious edema. 6)Serious peripheral neuropathy. 7)Positive for HBs antigen. 8)Complication which requires prior pre-treatment with corticosteroid. 9)Previous history or receiving treatment of dementia or serious psychiatric disorder. 10)Heterochrony or synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS). 11)Active multiple cancer (Non-invasive tumor or disease free periods after treatment are more than two years, considered to be non-activity). 12)Prior treatment with anticancer agents. 13)Ineligible based on decision of an investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological complete response rate
- Secondary Outcome Measures
Name Time Method (1) Safety (adverse events, incidence of cardiac disorders) (2) Overall response rate (3) Breast conserving rate (4) QpCR rate (5) CpCR and pN0 rate (6) SpCR rate