UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000020 |
|---|---|
| Receipt number | 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 15:58:37 |
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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
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
office@jbcrg.jp
Sponsor or person
Institute
Japan Breast Cancer Research Group(JBCRG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000028
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