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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000291
Receipt No. R000000368
Scientific Title Study of Docetaxel followed by FEC as primary systemic chemotherapy for operable breast cancer (JBCRG-03)
Date of disclosure of the study information 2005/11/25
Last modified on 2019/11/21

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Basic information
Public title Study of Docetaxel followed by FEC as primary systemic chemotherapy for operable breast cancer (JBCRG-03)
Acronym JBCRG-03(DOC-FEC as primary systemic chemotherapy)
Scientific Title Study of Docetaxel followed by FEC as primary systemic chemotherapy for operable breast cancer (JBCRG-03)
Scientific Title:Acronym JBCRG-03(DOC-FEC as primary systemic chemotherapy)
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the effectg and safety of Docetaxel followed by FEC as primary systemic chmeotehrapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Pathological responce, safety
Key secondary outcomes Clinical response, Breast conserving rate, Overall survival, Disease free survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Chemotherapy
Interventions/Control_2
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
60 years-old >
Gender Female
Key inclusion criteria T1c-3N0M0, T1-3N1M0
No previous treatment for breast cancer
Adequate organ function
Written informed consent
Key exclusion criteria Drug hypersensitivity
Severe complication
Inflammatory breast cancer
Double cancer
Bilateral breast cancer
Target sample size 130

Research contact person
Name of lead principal investigator
1st name Hiroji
Middle name
Last name Iwata
Organization Aichi Cancer Center Hospital
Division name Department of Breast Oncology
Zip code 464-8681
Address 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan
TEL 052-762-6111
Email hiwata@aichi-cc.jp

Public contact
Name of contact person
1st name Katsumasa
Middle name
Last name Kuroi
Organization JBCRG
Division name Head office
Zip code 103-0016
Address 9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
TEL 03-6264-8873
Homepage URL
Email office@jbcrg.jp

Sponsor
Institute Japan Breast Cancer Research Group (JBCRG)
Institute
Department

Funding Source
Organization Advanced Clinical Reseach Orginization (ACRO)
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 JBCRG
Address 9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
Tel 03-6264-8873
Email office@jbcrg.jp

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

Other administrative information
Date of disclosure of the study information
2005 Year 11 Month 25 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2005 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2005 Year 10 Month 01 Day
Last follow-up date
2009 Year 07 Month 01 Day
Date of closure to data entry
2009 Year 09 Month 01 Day
Date trial data considered complete
2009 Year 10 Month 01 Day
Date analysis concluded
2009 Year 12 Month 01 Day

Other
Other related information Presentations:The 15th Annual Meeting of the Japanese Breast Cancer Society(2007),The 16th Annual Meeting of the Japanese Breast Cancer Society(2008), 6hth EBCC
Papers:Biomed Pharmacother (2005,Oct; 59 Suppl 2:S387-92), BIG News Letter (2006, 8(1), Breast Cancer (2006,13(1), p38-48), JJBC(2007, 22(5), p372-375), European J of Cancer Suppl.(2008,16(7), p121),Japanese Journal of Clinical Oncology(2011, 41: 867-875)

Management information
Registered date
2005 Year 11 Month 25 Day
Last modified on
2019 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000368

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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