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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000020
Receipt No. R000000028
Scientific Title Study of fluorouracil, epirubicin and cyclophosphamide followed by docetaxel as preoperative chemotherapy in primary breast cancer (JBCRG-02)
Date of disclosure of the study information 2005/07/05
Last modified on 2019/11/21

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Basic information
Public title Study of fluorouracil, epirubicin and cyclophosphamide followed by docetaxel as preoperative chemotherapy in primary breast cancer (JBCRG-02)
Acronym JBCRG-02
(Study of FEC-DOC100 as primary systemic chemotherapy for operable breast cancer)
Scientific Title Study of fluorouracil, epirubicin and cyclophosphamide followed by docetaxel as preoperative chemotherapy in primary breast cancer (JBCRG-02)
Scientific Title:Acronym JBCRG-02
(Study of FEC-DOC100 as primary systemic chemotherapy for operable breast cancer)
Region
Japan

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

Objectives
Narrative objectives1 To evaluate clinical, histologic effect and safety of primary systemic chemotherapy using FEC followed by docetaxel in primary breast cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Safety, clinical and histologic effect
Key secondary outcomes Breast-conserving rate, 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 Fluorouracil 500 mg/m2, epirubicin 100 mg/m2, cyclophosphamide 500 mg/m2, q3w x 4 cycles, followed by Docetaxel 100 mg/m2, q3w x 4 cycles as Primary systemic 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 Histologically-proven breast cancer
T1c-3N0M0/T1-3N1M0
No prior therapy for breast cancer
Performance status 0-1
Adequate hematologic, renal, hepatic and cardica function
Written informed consent
Key exclusion criteria Hypersensitivity for drug
Serious coexisting illness
Active double cancer
Bilateral breast cancer
Male breast cancer
Pregnant or postpartum women
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Seigo
Middle name
Last name Nakamura
Organization St Luke's International Hospital
Division name Breast Center
Zip code 104-8560
Address 9-1 Akashi, Chuo-ku, Tokyo
TEL 03-3534-5151
Email seigonak@med.showa-u.ac.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 Research 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 Nihonbashikoamicho, Chuo-ku, Tokyo, 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 07 Month 05 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
Thirty-one patients were enrolled, and recruitment was closed.
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
2004 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 08 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
2011 Year 06 Month 01 Day
Date trial data considered complete
2011 Year 12 Month 01 Day
Date analysis concluded
2012 Year 01 Month 01 Day

Other
Other related information Meeting:2nd OOTR, 29nd SABCS(2006), 14th Annual meeting of Japanese Breast Cancer Society(2006), 15th Annual meeting of Japanese Breast Cancer Society(2007)

Paper:Biomed Pharmacother (2005Oct; 59 Suppl 2:S387-92), BIG News Letter(2006,8(1)),Breast Cancer(2006,13(1) p38-48), CCBJ (2007,23(2) p111-117)

Management information
Registered date
2005 Year 07 Month 05 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=R000000028

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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