UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062811 |
|---|---|
| Receipt number | R000071824 |
| Scientific Title | Treatment Preference Study of Adjuvant Endocrine Therapy in Hormone Receptor-Positive, HER2-Negative Early Breast Cancer |
| Date of disclosure of the study information | 2026/09/03 |
| Last modified on | 2026/09/03 18:42:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Treatment Preference Study of Adjuvant Endocrine Therapy in Hormone Receptor-Positive, HER2-Negative Early Breast Cancer
Acronym
Treatment Preference Study of Adjuvant Endocrine Therapy in Hormone Receptor-Positive, HER2-Negative Early Breast Cancer
Scientific Title
Treatment Preference Study of Adjuvant Endocrine Therapy in Hormone Receptor-Positive, HER2-Negative Early Breast Cancer
Scientific Title:Acronym
Treatment Preference Study of Adjuvant Endocrine Therapy in Hormone Receptor-Positive, HER2-Negative Early Breast Cancer
Region
| Japan |
Condition
Condition
Hormone receptor-positive, HER2-negative early breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to quantitatively evaluate the factors prioritized by patients during treatment decision-making in adjuvant endocrine therapy for HR+/HER2- early breast cancer in Japan, as well as to describe the implementation of shared decision making in real-world practice.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relative importance of each attribute and preference weights of each level evaluated by discrete choice experiment
Key secondary outcomes
Relative importance of each attribute and preference weights of each level by subgroups based on patient background and clinical characteristics
Marginal rate of substitution indicators (e.g., maximum acceptable risk) showing trade-off relationships between attributes
Survey response results (descriptive statistics) regarding Control Preferences Scale, physician-patient communication status, actual status of adverse events, and level of concern regarding recurrence risk
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients with HR-positive, HER2-negative breast cancer
Having history of curative surgery for breast cancer
Currently receiving adjuvant endocrine therapy
Female aged 18 years or older at the time of providing consent
Residing in Japan
Capable of understanding the study and providing informed consent
Having an appropriate device and internet connection to participate in online interviews/surveys
Key exclusion criteria
Having experience with pharmacotherapy for metastatic or recurrent breast cancer
Having history or presence of double cancer other than breast cancer
Current or past employment at a pharmaceutical company, or healthcare professional background for the participant, or current employment at a pharmaceutical company or healthcare professional status for cohabiting family members
Diagnosis of dementia
Participation in the cognitive debriefing interview study for questionnaire validation
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Harufuku |
Organization
Chugai Pharmaceutical Co., Ltd.
Division name
Medical Affairs Division
Zip code
103-8324
Address
2-1-1 Nihonbashi Muromachi, Chuo-ku, Tokyo
TEL
03-3281-6611
cmastudy@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Kusaka |
Organization
SSRI Co., Ltd.
Division name
Health Outcomes Research
Zip code
162-0067
Address
NMF Shinjuku EAST Bldg., 10-5 Tomihisacho, Shinjuku-ku, Tokyo
TEL
03-6709-9710
Homepage URL
HOR@ssri.com
Sponsor or person
Institute
Chugai Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
SSRI Co., Ltd.
Name of secondary funder(s)
Not applicable
IRB Contact (For public release)
Organization
Ethics Review Committee, Kitamachi Clinic, Toukeikai Medical Corporation
Address
1-1-3 Kichijoji-Kita-machi, Musashino-shi, Tokyo
Tel
03-6779-8166
chi-pr-ec-kitamachi@cmicgroup.com
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
該当なし
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 03 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 05 | Day |
Date of closure to data entry
| 2027 | Year | 01 | Month | 05 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2026 | Year | 09 | Month | 03 | Day |
Last modified on
| 2026 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071824
