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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
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 | 2020/05/11 |
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 |
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Condition | ||
Condition | Patients with breast cacner and bone metastasis | |
Classification by specialty |
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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 | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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Division name | Developmental Therapeutics | ||||||
Zip code | |||||||
Address | 6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan | ||||||
TEL | +81-4-7133-1111 | ||||||
ynaito@east.ncc.go.jp |
Public contact | |||||||
Name of contact person |
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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 | ||||||
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 | |
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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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | not recruiting |
Management information | |||||||
Registered date |
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Last modified on |
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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 |