UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047049 |
|---|---|
| Receipt number | R000053672 |
| Scientific Title | A multicenter observational study to explore risk factors for early recurrence in patients with hormone receptor-positive HER2-negative early breast cancer(WJOG15721B) |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2023/12/07 15:34:34 |
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Basic information
Public title
A multicenter observational study to explore risk factors for early recurrence in patients with hormone receptor-positive HER2-negative early breast cancer(WJOG15721B)
Acronym
RealisE
Scientific Title
A multicenter observational study to explore risk factors for early recurrence in patients with hormone receptor-positive HER2-negative early breast cancer(WJOG15721B)
Scientific Title:Acronym
RealisE
Region
| Japan |
Condition
Condition
Hormone receptor positive and HER2 negative early breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify risk factors for early recurrence in patients receiving postoperative endocrine therapy for Stage II-III hormone receptor positive and HER2 negative breast cancer
Basic objectives2
Others
Basic objectives -Others
Prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3-year invasive disease-free survival (IDFS) rate
Key secondary outcomes
IDFS, overall survival, 3-year distant recurrence free survival (DRFS) rate, DRFS
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Female>=20 years of age at the time of diagnosis of breast cancer.
2) The patient is histologically diagnosed with invasive breast cancer
3) The patient has confirmed ER positive or PgR positive breast cancer.
4) The patient has confirmed HER2 negative breast cancer.
5) The patient must have undergone surgery as initial treatment for clinical Stage II-III, hormone receptor positive (HR) positive, HER2 negative breast cancer. It does not matter whether the patient has received neoadjuvant chemotherapy or adjuvant chemotherapy.
6) The patient has started postoperative endocrine therapy between January 1, 2012, and January 1, 2017. Any duration of postoperative endocrine therapy administration is acceptable.
Key exclusion criteria
1)Patients judged to be inappropriate for inclusion by the physician.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Rurina |
| Middle name | |
| Last name | Watanuki |
Organization
National Cancer Center Hospital East
Division name
Department of Breast Surgery
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi, Chiba,Japan
TEL
04-7133-1111
rwatanuk@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Nakamura |
| Middle name | |
| Last name | Shinichiro |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka,JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Eli Lilly Japan K.K.
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
Showa University Research Ethics Review Board
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
m-rinri@ofc.showa-u.ac.jp
m-rinri@ofc.showa-u.ac.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
| 2022 | Year | 03 | 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
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
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective chart review using pre-existing data from patients with primary breast cancer
Management information
Registered date
| 2022 | Year | 03 | Month | 01 | Day |
Last modified on
| 2023 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053672
