UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000320 |
|---|---|
| Receipt number | R000000410 |
| Scientific Title | Validation study of FEC followed by docetaxel as preoperative chemotherapy in primary beast cancer (JBCRG-02') |
| Date of disclosure of the study information | 2006/02/02 |
| Last modified on | 2019/11/21 15:57:28 |
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Basic information
Public title
Validation study of FEC followed by docetaxel as preoperative chemotherapy in primary beast cancer (JBCRG-02')
Acronym
Validation study of FEC followed by docetaxel as preoperative chemotherapy in primary beast cancer (JBCRG-02')
Scientific Title
Validation study of FEC followed by docetaxel as preoperative chemotherapy in primary beast cancer (JBCRG-02')
Scientific Title:Acronym
Validation study of FEC followed by docetaxel as preoperative chemotherapy in primary beast cancer (JBCRG-02')
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
validation of efficacy and safety of JBCRG-02
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Safety, clinical and pathological response
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
Primary systemic chemotherapy: fluorouracil 500 mg/m2, epirubicin 100 mg/m2, cyclophosphamide 500 mg/m2, q3w x 4 cycles + Docetaxel 100 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
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
Histologiccally-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 drugs
Serious coexisting illness
Active double cancer
Bilateral breast cancer
Male breast cancer
Pregnant or postpartum wemen
Target sample size
20
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
03-3541-5151
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
https://jbcrg.jp/
office@jbcrg.jp
Sponsor or person
Institute
Japan Breast Cancer Reaserch Group (JBCRG)
Institute
Department
Personal name
Funding Source
Organization
Advanced Clinical Reaserch Organization (ACRO)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
JBCRG
Address
9-4 Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, 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
| 2006 | Year | 02 | Month | 02 | 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 | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 12 | 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
Presentation:14th&15th Annual meeting of Japanese Breast Cancer Society(2006&2007),
2nd OOTR(2005), 29th SABCS(2006)
Paper: Biomed Pharmacother(2005, Oct;59 Suppl 2:S387-92), BIG News Letter(2006, 8(1)), Breast Cacer(2006, 13(1) p38-48), JJBC(2007,23(2), p111-117)
Management information
Registered date
| 2006 | Year | 02 | Month | 02 | 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=R000000410
