UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050760 |
|---|---|
| Receipt number | R000057841 |
| Scientific Title | A cross-sectional, web-based survey of physicians in breast cancer treatment to reveal the underserved patient population who do not receive CDK4/6 inhibitor plus endocrine therapy and to identify the challenges of the disparity in Japan |
| Date of disclosure of the study information | 2023/04/10 |
| Last modified on | 2023/04/04 11:54:29 |
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Basic information
Public title
A cross-sectional, web-based survey of physicians in breast cancer treatment to reveal the underserved patient population who do not receive CDK4/6 inhibitor plus endocrine therapy and to identify the challenges of the disparity in Japan
Acronym
A cross-sectional, web-based survey of physicians in breast cancer treatment to reveal the underserved patient population who do not receive CDK4/6 inhibitor plus endocrine therapy and to identify the challenges of the disparity in Japan
Scientific Title
A cross-sectional, web-based survey of physicians in breast cancer treatment to reveal the underserved patient population who do not receive CDK4/6 inhibitor plus endocrine therapy and to identify the challenges of the disparity in Japan
Scientific Title:Acronym
A cross-sectional, web-based survey of physicians in breast cancer treatment to reveal the underserved patient population who do not receive CDK4/6 inhibitor plus endocrine therapy and to identify the challenges of the disparity in Japan
Region
| Japan |
Condition
Condition
HR+/HER2- advanced breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To describe current first-line treatment patterns (e.g., CDK4/6 inhibitor plus endocrine therapy, hormone monotherapy, and chemotherapy) for patients with HR+/HER2- advanced breast cancer.
Basic objectives2
Others
Basic objectives -Others
To identify challenges in prescribing CDK4/6 inhibitor plus endocrine therapy as a first-line treatment for patients with HR+/HER2- advanced breast cancer.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage share of each treatment option (e.g., CDK4/6 inhibitor plus endocrine therapy, hormone monotherapy, chemotherapy) as first-line treatment for patients with HR+/HER2- advanced breast cancer
Key secondary outcomes
Challenges to prescribe CDK4/6 inhibitor plus endocrine therapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Physicians who treated at least three first-line patients with HR+/HER2- advanced breast cancer in the past year.
2. Physicians who agree to participate in this web-based survey.
3. Physicians who have answered all the web-based questions.
Key exclusion criteria
There are no exclusion criteria for this study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Nakayama |
Organization
Osaka International Cancer Institute
Division name
Breast & Endocrine Surgery
Zip code
541-8567
Address
3-1-69, Otemae, Chuo-ku, Osaka-shi, Osaka
TEL
06-6945-1181
taqnakayama@hotmail.com
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Nakayama |
Organization
Osaka International Cancer Institute
Division name
Breast & Endocrine Surgery
Zip code
541-8567
Address
3-1-69, Otemae, Chuo-ku, Osaka-shi, Osaka
TEL
06-6945-1181
Homepage URL
taqnakayama@hotmail.com
Sponsor or person
Institute
Pfizer Japan Inc.
Institute
Department
Personal name
Funding Source
Organization
Pfizer Japan Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka International Cancer Institute
Address
3-1-69, Otemae, Chuo-ku, Osaka-shi, Osaka
Tel
06-6945-1181
rinri01@opho.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 10 | 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
300
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The physician panel owned by M3 Inc. will be utilized in this web-based survey. In this survey, the physicians will be asked about their attribute information (e.g., age, specialty, affiliated department, type and region of hospital), working environment (e.g., number of breast cancer specialist in hospital), and the outcomes (e.g., percentage share of each treatment option as first-line treatment for patients with HR+/HER2- advanced breast cancer). Physicians will submit their responses via a web-based survey.
Management information
Registered date
| 2023 | Year | 04 | Month | 04 | Day |
Last modified on
| 2023 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057841
