UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012817 |
|---|---|
| Receipt number | 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 15:44:40 |
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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
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
hikaise3632@yahoo.co.jp
Sponsor or person
Institute
JONIE Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014975
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| Registered date | File name |
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| Registered date | File name |
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