UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010807 |
|---|---|
| Receipt number | R000012572 |
| Scientific Title | A study on the effect of improving the QOL (quality of life), response and safety of eribulin mesylate for inoperable or recurrent breast cancer |
| Date of disclosure of the study information | 2013/05/26 |
| Last modified on | 2013/05/26 22:41:48 |
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Basic information
Public title
A study on the effect of improving the QOL (quality of life), response and safety of eribulin mesylate for inoperable or recurrent breast cancer
Acronym
A Study on QOL, response and safety of eribulin for inoperable or recurrent breast cancer
Scientific Title
A study on the effect of improving the QOL (quality of life), response and safety of eribulin mesylate for inoperable or recurrent breast cancer
Scientific Title:Acronym
A Study on QOL, response and safety of eribulin for inoperable or recurrent breast cancer
Region
| Japan |
Condition
Condition
inoperable or recurrent breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To study on the effect of improving the QOL, response and safety of eribulin mesylate for inoperable or recurrent breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effect of improving the QOL(Quality of life) evaluated by the FACT-B
Key secondary outcomes
- OSS (objective response rate) evaluate by RECIST
- Safety
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
eriburin mesylate 1.4mg/m2, days 1 and 8, q21 days.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Patients with history of prior treatment with anthracycline and taxane.
- Written informed consent was obtained
Key exclusion criteria
- patients with advanced bone marrow suppression.
- patients who has an anamnesis of hypersensitivity to the ingredient of this agent.
- pregnant women or the women that may have become pregnant
- patients simultaneously treatmented by trastuzumab or lapatinib.
- patients who judged that it was unsuitable as other candidates
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Haga |
Organization
Nippon Medical School
Division name
Department of Breast Surgery
Zip code
Address
Sendagi 1-1-5, Bunkyo-ku, Tokyo 113-8603, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nippon Medical School
Division name
Department of Breast Surgery
Zip code
Address
Sendagi 1-1-5, Bunkyo-ku, Tokyo 113-8603, Japan
TEL
Homepage URL
Sponsor or person
Institute
Department of Breast Surgery, Nippon Medical School
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
| 2013 | Year | 05 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 08 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 26 | Day |
Last modified on
| 2013 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012572
