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

Email

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


Email

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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020104


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name