UMIN-CTR Clinical Trial

Public title

Cohort study evaluating the efficacy of denosumab to protect against aromatase inhibitor-induced bone loss in Japanese breast cancer patients.

Acronym

Cohort study evaluating the efficacy of denosumab to protect against aromatase inhibitor-induced bone loss in Japanese breast cancer patients. (CYBORG003)

Scientific Title

Cohort study evaluating the efficacy of denosumab to protect against aromatase inhibitor-induced bone loss in Japanese breast cancer patients.

Scientific Title:Acronym

Cohort study evaluating the efficacy of denosumab to protect against aromatase inhibitor-induced bone loss in Japanese breast cancer patients. (CYBORG003)

Region

Japan

Condition

Breast Cancer
Osteoporosis

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this study is to evaluate the efficacy and safety of denosumab to protect against aromatase inhibitor-induced bone loss in Japanese breast cancer patients who are undergoing adjuvant aromatase inhibitor therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Bone mineral density changes

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

1. Non-metastatic breast cancer patients within 6 months after commencing postoperative aromatase inhibitor treatment.
2. Bone mineral densities have been measured within 1 month before/after commencing aromatase inhibitor treatment.
3. Subject is willing and able to provide signed consent.

Key exclusion criteria

1. Subject with prior allergy history to therapeutic agents used in this study
2. Evidence of with hypocalcemia
3. Known renal deficiency
4. Any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results.

Target sample size

500

Name of lead principal investigator

1st name
Middle name
Last name	TAKAFUMI SANGAI

Organization

Chiba University Graduate School of Medicine

Division name

Department of General Surgery

Zip code

Address

1-8-1 Inohana Chuo-ku Chiba, Japan 260-8670

TEL

043-226-2269

Email

sangai-jpn@umin.net

Name of contact person

1st name
Middle name
Last name	TAKAFUMI SANGAI

Organization

Chiba University Graduate School of Medicin

Division name

Department of General Surgery

Zip code

Address

1-8-1 Inohana Chuo-ku Chiba, Japan 260-8670

TEL

043-226-2269

Homepage URL

Email

sangai-jpn@umin.net

Institute

CYBORG (Chiba Youth Breast Oncology Research Group)

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

亀田総合病院（千葉県）
千葉県がんセンター（千葉県）
千葉大学医学部附属病院（千葉県）
東京歯科大学市川総合病院（千葉県）
船橋市立医療センター（千葉県）

Date of disclosure of the study information

2014

Year

08

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

The number of registered patient is too small than expected, so we are unable to make a planned analysis.

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

Recruitment status

Terminated

Date of protocol fixation

2014

Year

05

Month

20

Day

Date of IRB

Anticipated trial start date

2014

Year

09

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1. At the patient registration
* Age, height, weight, PS
* Past history, history of present illness, family history
* Pathological findings of primary tumor
(TNM classification, grading, Ki-67 expression status, number of lymph node metastasis, hormone receptor expression status, HER2 receptor expression status)
* Treatment content
(history of surgery, date of surgery, history of chemotherapy, history of irradiation treatment, start date and type of aromatase inhibitor, denosumab administration start date, the presence or absence of treatment for bone mineral loss, the contents of treatment for bone mineral loss except denosumab)
* Bone mineral density (measurement date, BMD, YAM, T-score)
2. During the treatment, and at the end of the treatment
* Treatment content
* Bone mineral density
* The presence or absence of fracture
* Adverse events and laboratory values of grade 3 or higher
* Dose reduction, discontinuation, or change of drug
* Metastasis and recurrence
* Clinical outcome (the last follow up date, date of death, cause of death,)
3. Observation and survey schedule
At aromatase inhibitor start date, 6 months after, 12 months after, and then every year.
Observation and survey are allowed to perform within one month before or after the specified date.

Registered date

2014

Year

08

Month

26

Day

Last modified on

2016

Year

11

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017264