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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012817
Receipt No. R000014975
Scientific Title 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.
Date of disclosure of the study information 2014/01/11
Last modified on 2014/01/11

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Basic information
Public title 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.
Acronym JONIE 3 Study
Scientific Title 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.
Scientific Title:Acronym JONIE 3 Study
Region
Japan

Condition
Condition Operable early Breast Cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy/safety of Eribulin Mesilate followed by FEC100 compare with Weekly Paclitaxel followed by FEC100 as neoadjuvant chemotherapy in Stage 1-3B operable early breast cancer patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Incidence (%) more than Grade 1 in CTCAE v4.0 of peripheral neuropathy
Key secondary outcomes (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.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2 Eribulin Mesilate 1.4 mg/m2 for day-1/8 (1 cycle /21days),for 4 cycles (and Herceptin for the HER2-positive breast cancer), followed by FEC 100 (500/100/500) for 4 cycles.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
70 years-old >=
Gender Female
Key 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
Key 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
Target sample size 230

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norio Kohno
Organization Tokyo Medical University Hospital
Division name Breast Oncology
Zip code
Address Nishisinjuku 6-7-1, Shinjuku-ku, Tokyo 160-0023
TEL 03-3342-6111
Email nkohno@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Kaise
Organization Tokyo Medical University Hospital
Division name Breast Oncology
Zip code
Address Nishisinjuku 6-7-1, Shinjuku-ku,Tokyo 160-0023
TEL 03-3342-6111
Homepage URL
Email hikaise3632@yahoo.co.jp

Sponsor
Institute JONIE Study Group
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 弘前市立病院、弘前大学医学部付属病院(青森県)、市立秋田総合病院(秋田県)、群馬大学医学部付属病院(群馬県)、帝京大学ちば医療センター、千葉大学医学部付属病院(千葉県)、東京医科大学病院、東京医科大学八王子医療センター、東京共済病院、関東中央病院(東京都)、虎ノ門病院(東京都)、横浜市立大学市民総合医療センター、北里大学病院、横浜栄共済病院(神奈川県)、総合上飯田第一病院(愛知県)、大阪大学医学部付属病院、淀川キリスト教病院、茶屋町ブレストクリニック、大阪府済生会中津病院(大阪府)、京都府立医科大学附属病院(京都府)、神戸大学医学部付属病院、兵庫県立がんセンター、兵庫県立西宮病院、兵庫医科大学病院、甲南病院、こくふブレストクリニック(兵庫県)、和歌山県立医科大学紀北分院、公立那賀病院(和歌山県)

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 11 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2013 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 11 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 01 Month 10 Day
Last modified on
2014 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014975

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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