UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011976 |
|---|---|
| Receipt number | R000013780 |
| Scientific Title | Observation study to examine the efficacy of 500mg Fluvestrant that targets ER(+) postmenopausal metastatic breast cancer patients (>1st line). |
| Date of disclosure of the study information | 2013/10/07 |
| Last modified on | 2019/04/12 19:43:44 |
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Basic information
Public title
Observation study to examine the efficacy of 500mg Fluvestrant that targets ER(+) postmenopausal metastatic breast cancer patients (>1st line).
Acronym
PerSeus -BC03
Scientific Title
Observation study to examine the efficacy of 500mg Fluvestrant that targets ER(+) postmenopausal metastatic breast cancer patients (>1st line).
Scientific Title:Acronym
PerSeus -BC03
Region
| Japan |
Condition
Condition
ER-positive postmenopausal metastatic/inoperable breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of 500mg Fluvestrant therapy in patients with inoperable or metastatic ER-positibe postmenopausal breast cancer within 2-4 ET regimens.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Clinicalbenefitrate
Overallresponse rate
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. Written informed consent
2. Patients who were histologically or cytologically diagnosed as inoperable/metastatic breast cancer.
3.Postmenopausal (no limit of age). In case of postchemothrapy, amenorrhea during >1 year. In patients who underwent LH-RH ag, the level of FSH and E2 were in level of postmenopausal condition.
4. ER-positibe in primary or metastatic lesions.
5.Patients whose prognosis would be anticipated More than 6 months.
6.PS 0/1 (2 with bone metastasis)
7.Sufficient major organ functions.
8. Patients with (1)measurable regions by RECIST. (2)Bone metastasis detected by CT, MRI, Bone scinti, or PET.
9. Either zoledronic acid, denosumab, RT for local therapy are acceptable.
* Re-biopsy will be preferable. ER, Ki67 should be estimated under each institutional criteria such as Allred, J-score.
Key exclusion criteria
1.Life threatening including large liver metastasis, larege brain metastasis, systematic inflammatory lymphangitis in lung.
2.Inflammatory breast cancer
3.Previous therapy by Fluvestrant.
4.Patients who accetted >4th ET.
5. Allergy to Fluvestrant.
6.Patients considered ineligible by the attending physician.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Yoshida |
Organization
Gifu University
Graduate school of medicine
Division name
Department of Srugical Oncology
Zip code
Address
1-1 Yanagido Gifu, Japan
TEL
058-230-6000
kyoshida@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Manabu Futamura |
Organization
Gifu University
Division name
Departmentofbreast and molecular oncology
Zip code
Address
1-1 Yanagido Gifu, Japan
TEL
058-230-6000
Homepage URL
mfutamur@gifu-u.ac.jp
Sponsor or person
Institute
PerSeUS:Perpetual Study estimated -by United Sections in Gifu
Institute
Department
Personal name
Funding Source
Organization
Office of PerSeUS
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 | 10 | Month | 07 | 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
| 2013 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 03 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 02 | Month | 01 | Day |
Other
Other related information
Add related study
Management information
Registered date
| 2013 | Year | 10 | Month | 07 | Day |
Last modified on
| 2019 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013780
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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