UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006965 |
|---|---|
| Receipt number | R000008225 |
| Scientific Title | Phase II clinical study of eribulin monotherapy in Japanese patients with metastatic breast cancer who presented well-defined taxane resistance |
| Date of disclosure of the study information | 2012/01/04 |
| Last modified on | 2017/11/30 18:08:18 |
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Basic information
Public title
Phase II clinical study of eribulin monotherapy in Japanese patients with metastatic breast cancer who presented well-defined taxane resistance
Acronym
Phase II clinical study of eribulin monotherapy in Japanese patients with metastatic breast cancer who presented well-defined taxane resistance
Scientific Title
Phase II clinical study of eribulin monotherapy in Japanese patients with metastatic breast cancer who presented well-defined taxane resistance
Scientific Title:Acronym
Phase II clinical study of eribulin monotherapy in Japanese patients with metastatic breast cancer who presented well-defined taxane resistance
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of Eribulin in patients with Taxane-resisted Metastatic breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Clinical Benefit Rate
Key secondary outcomes
EORTC QLQ-C30
Progression Free Survival
Overall Survival
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
1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
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)female patient who were histologically or cytologically confirmed as breast cancer
2)previously treated with chemotherapeutic regimens including an anthracycline and a taxane:
relapse during or within a year after neoadjuvant or post-operative adjuvant chemothrapy
with a taxane immediately before the study
progression during chemothrapy with a taxane in the metastatic setting
3)aged more than 20years and less than 75 years
4)ECOG PS of 0-2
5)having measurable lesion according to RECIST
6)adequate organ functions confirmed with following major examination:
neutrophil count more than 1500/microl
platelet count more than 100,000/microl
hemoglobin more than 8.0g/dL
AST,ALT less than 2.5 times the upper limit of nomal (ULN)
total bilirubin less than 1.5 times the upper limit of nomal (ULN)
serum creatinine less than 1.5 times the upper llimit of nomal (ULN)
7)obtained written informed consent
Key exclusion criteria
1)having systemic infection with a fever of 38 degrees or more
2)pleural effusion, ascites, or pericardial fluid requiring drainage
3)brain metastasis with clinical symptoms
4)patient with following serious complication
ischaemic heart disease or heart disease such as arrhythmia not controllable by treatment
myocardial infarction < 6 months prior to study entry
hepatic cirrhosis
interstitial pneumonia or pulmonary fibrosis
bleeding tendency
5)having active double cancer
6)HER2 over-expressed
7)pregnancy, breast-feeding or women with childbearing potential
8)judged by the investigator not to be appropriate for the study
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Inoue |
Organization
Saitama Cancer Center
Division name
Division of Breast Oncology
Zip code
Address
780 Komuro, Ina-machi, Kita-Adachi-gun, Saitama, Japan
TEL
048-722-1111
ino@cancer-c.pref.saitama.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Kai |
Organization
Saitama Breast Cancer Clinical Study Group (SBCCSG)
Division name
Secretariat Division (Shintoshin Ladies' Mammo Clinic)
Zip code
Address
3F Capital Building ,4-261-1 kishiki-cho, omiya-ku, saitama-shi
TEL
048-600-1722
Homepage URL
http://www.sbccsg.org/
toshikai@sbccsg.org
Sponsor or person
Institute
Saitama Breast Cancer Clinical Study Group (SBCCSG)
Institute
Department
Personal name
Funding Source
Organization
Saitama Breast Cancer Clinical Study Group (SBCCSG)
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
埼玉県立がんセンター，さいたま赤十字病院，自治医大さいたま医療センター，埼玉社会保険病院，赤心堂病院，春日部市立病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 04 | 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
| 2011 | Year | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 11 | 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
| 2011 | Year | 12 | Month | 27 | Day |
Last modified on
| 2017 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008225
