UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000013780