UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000916 |
|---|---|
| Receipt number | R000001060 |
| Scientific Title | Randomized study of docetaxel or weekly paclitaxel followed by 5FU + epirubicin + cyclophosphamide as preoperative chemotherapy for primary breast cancer |
| Date of disclosure of the study information | 2007/12/01 |
| Last modified on | 2011/12/01 10:47:10 |
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Basic information
Public title
Randomized study of docetaxel or weekly paclitaxel followed by 5FU + epirubicin + cyclophosphamide as preoperative chemotherapy for primary breast cancer
Acronym
Randomized study of docetaxel or weekly paclitaxel followed by 5FU + epirubicin + cyclophosphamide as preoperative chemotherapy for primary breast cancer(KBCOG-06)
Scientific Title
Randomized study of docetaxel or weekly paclitaxel followed by 5FU + epirubicin + cyclophosphamide as preoperative chemotherapy for primary breast cancer
Scientific Title:Acronym
Randomized study of docetaxel or weekly paclitaxel followed by 5FU + epirubicin + cyclophosphamide as preoperative chemotherapy for primary breast cancer(KBCOG-06)
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 compare efficacy and safety of two taxane containg regimen, docetaxel given every three weeks versus weekly paclitaxel , followed by FEC regimnen as preoperative chemotherapy for primary breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pathological complete response rate
Key secondary outcomes
clinical response rate, safety, breast conserving rate, progression free survival, overall survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
docetaxel 75mg/m2 every three weeks, four cycles
Interventions/Control_2
paclitaxel 80mg/m2 day1, 8, 15, every three weeks, four cycles
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
| Not applicable |
Gender
Female
Key inclusion criteria
1) histologically proven primary breast cancer with information about ER, PgR, Her2 status
2) clinical stage II or IIIA
3) no history of chemotherapy
4) no history of surgery against breast cancer
5) ECOG PS0, 1, 2
6) adequate organ function
Key exclusion criteria
1) severe comorbidity
2) alergy to polysorbate 80
3) alergy to clemohol EL
4) active infection
5) severe peripheral neuropathy
6) alcohol intolerance
7) pregnant or lactating women
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Matsumoto |
Organization
Hyogo Cancer Center
Division name
medical oncology division
Zip code
Address
13-70, Kitaoji-cho, Akashi, Hyogo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hyogo Cancer Center
Division name
medical oncology division
Zip code
Address
TEL
Homepage URL
kojmatsu@hp.pref.hyogo.jp
Sponsor or person
Institute
kobe breast cancer oncology group
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
| 2007 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
No longer recruiting
Date of protocol fixation
| 2007 | Year | 11 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 11 | Month | 30 | Day |
Last modified on
| 2011 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001060
