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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000011
Receipt No. R000000020
Scientific Title Study of cyclophosphamide, epirubicin and fluoraouracil followed by docetaxel (CEF-DOC) as preoperative chemotherapy in primary operable breast cancer
Date of disclosure of the study information 2005/06/22
Last modified on 2019/11/21

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Basic information
Public title Study of cyclophosphamide, epirubicin and fluoraouracil followed by docetaxel (CEF-DOC) as preoperative chemotherapy in primary operable breast cancer
Acronym JBCRG-01
(Study of CEF-DOC as primary systemic chemotherapy for operable berast cancer)
Scientific Title Study of cyclophosphamide, epirubicin and fluoraouracil followed by docetaxel (CEF-DOC) as preoperative chemotherapy in primary operable breast cancer
Scientific Title:Acronym JBCRG-01
(Study of CEF-DOC as primary systemic chemotherapy for operable berast 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 The purpose of this study is to evaluate the feasibility and safety as well as clinical and pathological response of cyclophosphamide, epirubicin and fluorouracil (CEF) followed by docetaxel (DOC) as primary systemic chemotherapyin patients with operable breast cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Clinicl response, pathologic response, safety
Key secondary outcomes 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 Maneuver
Interventions/Control_1 Primary systemic chemotherapy (cyclophosphamide 500 mg/m2, epirubicin 100 mg/m2 and fluorouracil 500 mg/m2, q3w x 4 cycles, followed by docetaxel 75 mg/m2, q3w x 4 cycles
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
65 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 cardiac 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 200

Research contact person
Name of lead principal investigator
1st name 1)Masakazu 2)Yuichi
Middle name
Last name 1)Toi 2)Takatsuka
Organization 1)Graduate School of Medicine Kyoto University 2)Kansai Rosai Hospital
Division name 1)Department of Surgery (Breast Surgery) 2)Department of Breast Surgery
Zip code 606-8507
Address 54 Kawara-cho Shogoin Sakyo-ku, Kyoto, 606-8507 Japan
TEL 075-751-3660
Email toi@kuhp.kyoto-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 https://jbcrg.jp/
Email office@jbcrg.jp

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

Funding Source
Organization Osaka Cancer Research Foundation, Advanced Clinical Research Organization
Organization
Division
Category of Funding Organization Non profit foundation
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 06 Month 22 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
Totally 202 patients were enrolled, and final clinical resposne, safety and pCR data were published (Breast Cancer Res Treat. 2007).
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
2002 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date
2002 Year 06 Month 01 Day
Last follow-up date
2007 Year 01 Month 01 Day
Date of closure to data entry
2007 Year 01 Month 01 Day
Date trial data considered complete
2007 Year 01 Month 01 Day
Date analysis concluded
2007 Year 03 Month 01 Day

Other
Other related information Presentation: The 11th Annual Meeting of Jpn Breast Cancer Soc (2003), The 41st Annual Meeting of Jpn Soc for Cancer Ther (2003), The 15th ICACT(2004), The 12th Annual Meeting of Jpn Breast Cancer Soc (2004), The 1st Annual Meeting of OOTR (2004), The 27th SABCS(2004), The 13th Annual Meeting of Jpn Breast Cancer Soc (2005),5th EBCC(2006), 3rd OOT(2006)
Papers:Breast Cancer (12:99-103, 2005)

Management information
Registered date
2005 Year 06 Month 14 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=R000000020

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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