Randomized controlled trial for peripheral neuropathy comparing weekly Paclitaxel followed by FEC100 with Eribulin Mesilate followed by FEC100 as neoadjuvant chemotherapy in primary breast cancer patients.
- Conditions
- Operable early Breast Cancer
- Registration Number
- JPRN-UMIN000012817
- Lead Sponsor
- JONIE Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 230
Not provided
(1)Non-invasive breast cancer and Invasive micropapillary carcinoma (2)Inflammatory breast caner (3) Bilateral breast cancer(synchronous or asynchrous) (4) No prior chemotherapy, endocrine therapy and radiotherapy for breast cancer (5) Active double cancer (6) Patients with myocardial infarction or congestive heart failure at the past history, or patients who need treatment of ischemic hear disease, arryhythmia or valvular disorder. (7) Severe complication (infectious diseases, interstitial pneumonia peripheral neuropathy, uncontrolled diabetes, bleeding tendency) (8) Those who are pregnant, potentially pregnant or breast-feeding (9) Those known to have active Hepatitis B or C Viral Infection (HBs(+) or HCV(+)) (10)Patients who have an allergy for alcohol (11) Patient judged inappropriate for this study by the physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence (%) more than Grade 1 in CTCAE v4.0 of peripheral neuropathy
- Secondary Outcome Measures
Name Time Method (1)Pathological complete response rate: pCR (2)Clinical response rate (3)Breast conserving rate (4)Disease free survival (5)PNQ (6)Adverse events (7) Association between Ki-67 index and DFS.