UMIN-CTR Clinical Trial

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
Last 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
Email	matsuiakira@kankakuki.go.jp

Public contact
1st 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
Email	matsuiakira@kankakuki.go.jp

Sponsor
Institute	Physician -managed clinical trial
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020104