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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011976
Receipt No. 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

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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
Email 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
Email mfutamur@gifu-u.ac.jp

Sponsor
Institute PerSeUS:Perpetual Study estimated -by United Sections in Gifu
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013780

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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