UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013596 |
|---|---|
| Receipt number | R000015824 |
| Scientific Title | Feasibility study of the bi-weekly administration of eribulin for metastatic breast cancer |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2014/04/01 21:25:23 |
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Basic information
Public title
Feasibility study of the bi-weekly administration of eribulin for metastatic breast cancer
Acronym
Feasibility study of the bi-weekly administration of eribulin for metastatic breast cancer
Scientific Title
Feasibility study of the bi-weekly administration of eribulin for metastatic breast cancer
Scientific Title:Acronym
Feasibility study of the bi-weekly administration of eribulin for metastatic breast cancer
Region
| Japan |
Condition
Condition
Metastatic breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety and efficacy of the bi-weekly administration of eribulin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ORR, overall response rate
Key secondary outcomes
Base
Study type
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
Eribulin
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
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
(1)The women histologically diagnosed as breast cancer
(2) The patients who received previous chemotherapy with anthracycline and taxane
(3)Age 20–75 years
(4)ECOG PS: 0-2
(5)The patients with the measurable lesion by RECIST version 1.1
(6)The patients with adequate organ function
(7)Written informed consent was obtained from each patient prior to enrollment.
Key exclusion criteria
Patients with serious complications, a history of drug hypersensitivity, brain metastases with any symptoms, active secondary cancer, or pregnant women were excluded.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Saeki |
Organization
Saitama Medical University International Medical Center
Division name
Department of Breast Oncology
Zip code
Address
1397-1 Yamane, Hidaka-shi, Saitama 350-1298, Japan
TEL
+81-42-984-4670
takshige@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Shigekawa |
Organization
Saitama Medical University International Medical Center
Division name
Department of Breast Oncology
Zip code
Address
1397-1 Yamane, Hidaka-shi, Saitama 350-1298, Japan
TEL
+81-42-984-4670
Homepage URL
takshige@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2014 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | 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
| 2014 | Year | 04 | Month | 01 | Day |
Last modified on
| 2014 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015824
