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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003261
Receipt No. R000003949
Scientific Title Randomized controlled trial comparing zoledronic acid plus chemotherapy with chemotherapy alone as a neoadjuvant treatment in patients with primary breast cancer
Date of disclosure of the study information 2010/03/01
Last modified on 2010/03/02

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Basic information
Public title Randomized controlled trial comparing zoledronic acid plus chemotherapy with chemotherapy alone as a neoadjuvant treatment in patients with primary breast cancer
Acronym JONIE Study
Scientific Title Randomized controlled trial comparing zoledronic acid plus chemotherapy with chemotherapy alone as a neoadjuvant treatment in patients with primary breast cancer
Scientific Title:Acronym JONIE Study
Region
Japan

Condition
Condition 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 zoledronic acid when given by intravenous infusion every 4 weeks in addition to FEC follwed by paclitaxel as neoadjuvant chemotherapy in Stage 2A-3B HER2-negative primary breast cancer patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Pathological complete response rate:pCR
Key secondary outcomes Clinical response rate
Breast conserving rate
Disease free survival
Adverse events

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 FEC100 (500/100/500 mg/m2) every 21 days for 4 cycles followed by weekly Paclitaxel 80 for 12 cycles (or weekly Paclitaxel 80 followed by FEC100).
Interventions/Control_2 Patients receive zoledronic acid 4mg or an adjusted dose used renal function IV over 15 minutes infusion every 3-4 weeks for 6 months ( 6-7 times infusion).
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.Histologicaly confirmed invasive breast cancer by biopsy.
2.Clinical stage 2A-3B defined as:
1) Tumor diamiter more than 3cm
2)Tumor diamiter more than 2cm and Node positive
3. HER2 negative (less 1 by HercepTest, if 2+ by HercepTest, negative by FISH)
4. Age more than 20 to less than 70 years
5. ECOG PS 0-1
6. Adequate main organ functions
1) WBC more than 3000/mm3 and Neutrophil more than 1500/mm3
2)Hemoglobin more than 9.0g/dl
3)Platelet more than 100,000/mm3
4) AST and ALT more less 2.5x upper limit of normal
5)Serum creatinine less than 1.5x upper limit of normal
6)Normal cardiac function
7)left ventricular ejection fraction
more than 50 %
7. 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. Current active dental problems including infection of the teeth or jawbone. Recent (within 6 weeks) or planned dental or jaw surgery(e.g., extraction, implants)
10.Those known to have active Hepatitis B or C Viral Infection ( HBs(+) or HCV(+) )
11. Patients have received prior intravenous bisphosphonate within 12 monthes
12. Patient judged inappropriate for this study by the physicians
Target sample size 180

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
TEL 03-3342-6111
Email

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
TEL 03-3342-6111
Homepage URL
Email kaise3632@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(青森県)、岩手医科大学病院(岩手県)、秋田大学病院(秋田県)、群馬大学病院(群馬県)、東京医科大学病院(東京都)、東京医科大学八王子医療センター(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(神奈川県)、帝京大学ちば医療センター(千葉県)、大阪大学病院(大阪府)、淀川キリスト教病院(大阪府)、神戸大学病院(兵庫県)、甲南病院(兵庫県)、川崎医科大学病院(岡山県)

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 01 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
2009 Year 11 Month 19 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
2017 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 02 Month 27 Day
Last modified on
2010 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003949

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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