UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009110 |
|---|---|
| Receipt number | R000010683 |
| Scientific Title | A observational study for safety and efficacy of Fulvestrant 500mg in postmenopausal patients with ER positive advanced or recurrent breast cancer after prior endocrine treatment. (SBCCSG-29) |
| Date of disclosure of the study information | 2012/10/15 |
| Last modified on | 2017/11/30 18:09:32 |
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Basic information
Public title
A observational study for safety and efficacy of Fulvestrant 500mg in postmenopausal patients with ER positive advanced or recurrent breast cancer after prior endocrine treatment. (SBCCSG-29)
Acronym
SBCCSG-29:Fulvestrant observational study
Scientific Title
A observational study for safety and efficacy of Fulvestrant 500mg in postmenopausal patients with ER positive advanced or recurrent breast cancer after prior endocrine treatment. (SBCCSG-29)
Scientific Title:Acronym
SBCCSG-29:Fulvestrant observational study
Region
| Japan |
Condition
Condition
Locally advanced or metastatic breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To collect and evaluate real-life data of patients with ER+ advanced breast cancer treated with Fulvestrant 500mg regimen.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Time to treatment failure(TTF)
Key secondary outcomes
Overall survival(OS),
Clinical benefit rate(CBR),
Response rate(RR),
Safety
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Female
Key inclusion criteria
1.Postmenopausal breast cancer.
2.Histological confirmation of breast cancer.
3.Histologically proven invasive breast cancer.
4.Patients who is receiving or planning to receive Fulvestrant therapy.
5.Prior endocrine therapy for breast cancer besides Fulvestrant therapy.
6.Estrogen receptor positive (>1% by IHC).
7.Adequate marrow, cardiac, kidney and liver function.
8.In principle signed written informed consent was obtained from patients.
Key exclusion criteria
1.Current or prior double cancer within 5 years.
2.Non-invasive breast cancer.
3.Inflammatory breast cancer.
4.An existing serious, uncontrolled cardiac disease.
5.Brain metastasis.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Kimuzuka |
Organization
Kasukabe Municipal Hospital
Division name
Surgery
Zip code
Address
7-2-1, chuo, Kasukabe-si, Saitama prefecture
TEL
048-735-1261
keisurg@cd5.so-net.ne.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, 330-0843, Japan
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
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
春日部市立病院（埼玉県），埼玉県立がんセンター（埼玉県），さいたま赤十字病院（埼玉県），自治医大さいたま医療センター（埼玉県），赤心堂病院（埼玉県），埼玉社会保険病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 15 | 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
| 2012 | Year | 09 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To collect and evaluate real-life data of patients with ER+ advanced breast cancer treated with Fulvestrant 500mg regimen.
Management information
Registered date
| 2012 | Year | 10 | Month | 14 | 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=R000010683
| 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 |
