Unique ID issued by UMIN | UMIN000016868 |
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Receipt number | 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 12:25:32 |
Bone Scan Index for Breast Cancer Bone Metastasis
BSI for Breast Cancer Bone Metastasis
Bone Scan Index for Breast Cancer Bone Metastasis
BSI for Breast Cancer Bone Metastasis
Japan |
Patients with breast cacner and bone metastasis
Hematology and clinical oncology |
Malignancy
NO
(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).
Efficacy
Exploratory
Not applicable
Progression-free survival (PFS)
skeletal-related event (SRE), Overall survival (OS)
Observational
20 | years-old | <= |
Not applicable |
Male and Female
(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
(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
200
1st name | |
Middle name | |
Last name | Yoichi Naito |
(1)Division of Developmental Therapeutics, Exploratory Oncology Research and Clinical Trial Center
(2)Division of Breast and Medical Oncology, National Cancer Center Hospital East
Developmental Therapeutics
6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan
+81-4-7133-1111
ynaito@east.ncc.go.jp
1st name | |
Middle name | |
Last name | Yoichi Naito |
National Cancer Center Hospital East
Division of Breast and Medical Oncology
6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan
+81-4-7133-1111
http://cspor-bc.or.jp/about/index.html
ynaito@east.ncc.go.jp
CSPOR-BC
FUJIFILM RI Pharma Co., Ltd.
Other
NO
2015 | Year | 03 | Month | 23 | Day |
Unpublished
Completed
2015 | Year | 01 | Month | 22 | Day |
2015 | Year | 01 | Month | 05 | Day |
2015 | Year | 04 | Month | 01 | Day |
2019 | Year | 12 | Month | 31 | Day |
not recruiting
2015 | Year | 03 | Month | 22 | Day |
2020 | Year | 05 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019577
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