Phase 2 study of dose-dense nab-paclitaxel followed by EC as neoadjuvant chemotherapy for HER2-negative breast cancer
Phase 2
Recruiting
- Conditions
- HER2-negative primary breast cancer
- Registration Number
- JPRN-UMIN000026143
- Lead Sponsor
- Teikyo University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1) Women who are pregnant or lactating 2) Multiple primary cancer 3) HER2-positive breast cancer 4) Poorly controlled complication (interstitial pneumonia, severe diabetes, heart failure, renal insufficiency, hepatic insufficiency) 5) Active infection 6) Serious peripheral neuropathy (>=CTCAE grade2) 7) 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 Clinical response rate, disease-free survival, adverse events, the evaluation of peripheral neuropathy by Patient Neurotoxicity Questionnaire (PNQ), the evaluation of QOL by FACT-Taxane