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.

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. - JONIE 3 Study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012817

Enrollment

230

Registered

2014-01-11

Start date

2014-01-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Operable early Breast Cancer

Interventions

Weekly Paclitaxel 80 mg/m2 for 12 cycles (and Herceptin for the HER2-positive breast cancer) followed by FEC 100 (500/100/500) for 4 cycles. Eribulin Mesilate 1.4 mg/m2 for day-1/8 (1 cycle /21days),f

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: (1) Woman who had confirmed histologicaly invasive breast cancer by biopsy. (2)Clinical stage 1-3B defined as: 1)Tumor diamiter >=2cm and HER2 negative (<1 by HercepTest, if 2+ by HercepTest, negative by FISH)/HR negative. 2)Tumor diamiter >=1cm and HER2 positive, HER2 negative and HR negative. (3) Age >=20 to <=70 years (4)ECOG PS 0-1 (5) Adequate main organ functions 1) WBC >= 3000/mm3 and Neutrophil >=1500/mm3 2)Hemoglobin >=9.0g/dl 3)Platelet>= 100,000/mm3 4) AST and ALT <=2.5x upper limit of normal 5)Serum creatinine <=1.5x upper limit of normal 6)Normal cardiac function 7)left ventricular ejection fraction >=50 % (6) Written informed consent

Exclusion criteria

Exclusion criteria: (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

Design outcomes

Primary

Measure	Time frame
Incidence (%) more than Grade 1 in CTCAE v4.0 of peripheral neuropathy	—

Secondary

Measure	Time frame
(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.	—

Countries

Japan

Contacts

Public ContactHiroshi Kaise

Tokyo Medical University Hospital Breast Oncology

hikaise3632@yahoo.co.jp03-3342-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026