UMIN-CTR Clinical Trial

Basic information
Public title	Bone Scan Index for Breast Cancer Bone Metastasis
Acronym	BSI for Breast Cancer Bone Metastasis
Scientific Title	Bone Scan Index for Breast Cancer Bone Metastasis
Scientific Title:Acronym	BSI for Breast Cancer Bone Metastasis
Region	Japan

Condition
Condition	Patients with breast cacner and bone metastasis
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	(1) To investigate the correlation between BSI and prognosis (Progression-free survival; PFS and overall survival; OS). (2) To investigate the correlation between BSI and skeletal-related event (SRE).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Progression-free survival (PFS)
Key secondary outcomes	skeletal-related event (SRE), Overall survival (OS)

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Histologically or cytologically diagnosed breast cancer (2) Bone metastasis (confirmed by biopsy, Xp, CT, or MRI) (3) Zoledronate or denosumab is planning to be administrated (4) Less than 3 prior systemic treatments (chemotherapy, endocrine therapy, or both) for metastatic disease (5) 20 years or older (6) ECOG PS 0 to 2 (7) Written informed consent (8) Adequate organ function
Key exclusion criteria	(1) Creatinine clearance <30 mL/min (2) Infection of jawbone, tooth, or patients planning to have surgery in tooth or jaw (3) Severe allergy to bisphosphonate (including zoledronate) or denosumab (4) Symptomatic brain metastasis or leptomeningitis (5) Spinal cord compression (6) Severe comorbidity (7) Bone metastasis from cancer other than breast cancer (8) Judged to be inappropriate for inclusion by physician
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoichi Naito
Organization	(1)Division of Developmental Therapeutics, Exploratory Oncology Research and Clinical Trial Center (2)Division of Breast and Medical Oncology, National Cancer Center Hospital East
Division name	Developmental Therapeutics
Zip code
Address	6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan
TEL	+81-4-7133-1111
Email	ynaito@east.ncc.go.jp

Public contact
Name of contact person	1st name Middle name Last name Yoichi Naito
Organization	National Cancer Center Hospital East
Division name	Division of Breast and Medical Oncology
Zip code
Address	6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan
TEL	+81-4-7133-1111
Homepage URL	http://cspor-bc.or.jp/about/index.html
Email	ynaito@east.ncc.go.jp

Sponsor
Institute	CSPOR-BC
Institute
Department

Funding Source
Organization	FUJIFILM RI Pharma Co., Ltd.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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IRB Contact (For public release)
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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	2015 Year 03 Month 23 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	No longer recruiting
Date of protocol fixation	2015 Year 01 Month 22 Day
Date of IRB	2015 Year 01 Month 05 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	not recruiting

Management information
Registered date	2015 Year 03 Month 22 Day
Last modified on	2019 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019577

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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