UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000291 |
|---|---|
| Receipt number | 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 | 2021/08/13 16:24:34 |
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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
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
office@jbcrg.jp
Sponsor or person
Institute
Japan Breast Cancer Research Group (JBCRG)
Institute
Department
Personal name
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
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
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/21719750/
Number of participants that the trial has enrolled
137
Results
Of the 132 patients assessable
for pathologic response, 23% experienced a pCR and 6% had a near pCR (few remaining cancer cells), resulting in a quasi-pCR of 29%.
Clinical RR following the initial DOC regimen was 64%. The overall clinical RR after completion of FEC was 79%.
Breast-conserving surgery was
performed in 79% of patients.
Results date posted
| 2021 | Year | 08 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2011 | Year | 07 | Month | 01 | Day |
Baseline Characteristics
Patients with operable primary breast cancer
Participant flow
4 cycles of DOC administered i.v. every 21 days were followed by 4 cycles of FEC administered i.v. on Day 1 every 21 days before surgery.
Adverse events
Neutropenia was the most common Grade 3/4 treatment-related AE and was observed in 44% and 60% of
patients during DOC and FEC therapy, respectively.
Outcome measures
Primary endpoints:
Pathological response, Safety
Secondary endpoints:
Clinical response
Breast-conserving surgery rate
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
| 2021 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000368
