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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016868
Receipt No. R000019577
Scientific Title Bone Scan Index for Breast Cancer Bone Metastasis
Date of disclosure of the study information 2015/03/23
Last modified on 2019/07/17

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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
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
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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