UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017328 |
|---|---|
| Receipt number | R000020104 |
| Scientific Title | Observational study to examine the usefulness of denosumab in postmenopausal breast cancer patients |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2019/05/05 15:22:39 |
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Basic information
Public title
Observational study to examine the usefulness of denosumab in postmenopausal breast cancer patients
Acronym
Observational study to examine the usefulness of denosumab in postmenopausal breast cancer patients
Scientific Title
Observational study to examine the usefulness of denosumab in postmenopausal breast cancer patients
Scientific Title:Acronym
Observational study to examine the usefulness of denosumab in postmenopausal breast cancer patients
Region
| Japan |
Condition
Condition
postmenopausal breast cancer patients
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of denosumab therapy in postmenopausal breast cancer patients with decreased bone mineral density
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Phase IV
Assessment
Primary outcomes
The change in bone mineral density ,
The change of bone metabolism markers , Safety
Key secondary outcomes
Bone metastasis-free survival , Recurrence-free survival ,
Survival
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
| 40 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Histologically confirmed breast cancer patients
2. Radical surgery and post-operative irradiation or chemotherapy has been completed.
3. ER and PgR status has been confirmed.
4. ECOG PS of 0-2 at the time of registration
5. Patients without a major organs dysfunction
6. Decreased bone density (T score -1 or less )
7. Patients who have written consent of participation
Key exclusion criteria
1. Patients with a history of hypersensitivity to aromatase inhibitors and denosumab
2. Patients with bone metastases
3. More than one year have passed after radical surgery.
4. More than six months have passed after start of denosumab
5. Patients undergoing treatment with bisphosphonates
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Matsui |
Organization
Ntional Hospital Organization
Tokyo Medical Center
Division name
Breast Suegery Department
Zip code
152-8902
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo
TEL
03-3411-0111
matsuiakira@kankakuki.go.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Matsui |
Organization
Ntional Hospital Organization
Division name
Breast Suegery Department
Zip code
152-8902
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo
TEL
03-3411-0111
Homepage URL
matsuiakira@kankakuki.go.jp
Sponsor or person
Institute
Physician -managed clinical trial
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ntional Hospital Organization Tokyo Medical Center
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo
Tel
03-3411-0111
HOhshima@ntmc.hosp.go.jp
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
東京医療センター （東京都）
東邦大学医療センター大橋病院 （東京都）
関東中央病院 （東京都）
東邦大学医療センター大森病院 （東京都）
JR東京総合病院 （東京都）
北里研究所病院 （東京都）
NTT東日本病院 （東京都）
日産厚生会玉川病院 （東京都）
大森赤十字病院 （東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 01 | 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
33
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
Terminated
Date of protocol fixation
| 2014 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
Management information
Registered date
| 2015 | Year | 04 | Month | 29 | Day |
Last modified on
| 2019 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020104
