UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000572 |
|---|---|
| Receipt number | R000000690 |
| Scientific Title | Efficacy and safety of first-line Vinorelbine single agent in patints with refractory to anthracycline and taxane |
| Date of disclosure of the study information | 2007/01/10 |
| Last modified on | 2014/05/07 09:32:38 |
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Basic information
Public title
Efficacy and safety of first-line Vinorelbine single agent in patints with refractory to anthracycline and taxane
Acronym
Efficacy and safety of first-line Vinorelbine single agent
Scientific Title
Efficacy and safety of first-line Vinorelbine single agent in patints with refractory to anthracycline and taxane
Scientific Title:Acronym
Efficacy and safety of first-line Vinorelbine single agent
Region
| Japan |
Condition
Condition
First-line metastatic breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of single agent Vinorelbine refractory to anthracycline and taxane
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Time to progression
Key secondary outcomes
Response rate, toxicity
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
vinorelbine
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1) First-line metastatic breast cancer
2) had adjuvant chemotherapy with anthracycline and taxane
3) negative for HER2/neu
4) PS0-2 (ECOG)
5) having measureable lesion according to RECIST
6) survival longer than 3 months
7) having adequete organ function
8) obtained written informed consent
Key exclusion criteria
1) had another chemotherapy after recurrence
2) having active multiple cancers
3) having serious infenction or severe organ function
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuneo Imai |
Organization
Nagoya University school of medicine
Division name
Department of Breast and Endocrine surgery
Zip code
Address
65 tsurumai-cho showa-ku Nagoya City
TEL
052-744-2251
m-sawaki@aichi-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masataka Sawaki |
Organization
Nagoya University school of medicine
Division name
Department of Breast and Endocrine surgery
Zip code
Address
65 tsurumai-cho showa-ku Nagoya City
TEL
052-744-2251
Homepage URL
sawapi@qc4.so-net.ne.jp
Sponsor or person
Institute
Department of Breast and Endocrine surgery, Nagoya University school of medicine
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 | 01 | Month | 10 | 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
Completed
Date of protocol fixation
| 2006 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 01 | Month | 05 | Day |
Last modified on
| 2014 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000690
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
