UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057077 |
|---|---|
| Receipt number | R000065145 |
| Scientific Title | A multi-institutional retrospective cohort study on dynamics of HER2 expression from primary site to metastatic or recurrent site in breast cancer |
| Date of disclosure of the study information | 2025/02/20 |
| Last modified on | 2025/05/23 14:07:38 |
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Basic information
Public title
A multi-institutional retrospective cohort study on dynamics of HER2 expression from primary site to metastatic or recurrent site in breast cancer
Acronym
HER2 PRIME study(JFMC52-2401-N1)
Scientific Title
A multi-institutional retrospective cohort study on dynamics of HER2 expression from primary site to metastatic or recurrent site in breast cancer
Scientific Title:Acronym
HER2 PRIME study(JFMC52-2401-N1)
Region
| Japan |
Condition
Condition
Brest Cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the dynamics of HER2 expression in breast cancer tissues over the course of treatment.
Basic objectives2
Others
Basic objectives -Others
To explore factors related to the dynamics in HER2 expression in breast cancer and optimize anti-HER2 therapy through an understanding of the dynamics of HER2 expression based on clinicopathological and biological characteristics.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)HER2 scoring of tumor tissue samples
2)Percentage of HER2-expressing cell composition by staining pattern in tumor tissue samples
3)Changes in HER2 expression from the primary site to metastatic or recurrent site in tumor tissue samples from the same patient
Key secondary outcomes
1)Changes in HER2 expression based on the timing or site of tumor tissue sample collection
2)Clinicopathological factors
3)Overall survival
4)Histological and morphological characteristics
5)Gene profiling
6)Protein expression analysis
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
Male and Female
Key inclusion criteria
1) Patients who are at least 18 years of age or older at the time of diagnosis of invasive breast cancer.
2) Patients diagnosed with histologically invasive breast cancer on or after January 1, 2013.
3) Patients diagnosed with histologically local recurrence or metastatic recurrence by December 31, 2023 after initial surgery for primary breast cancer.
4) Subjects where at least one tissue sample from the primary site (specimen at initial diagnosis and/or surgical resection specimen) and at least one tissue sample from the metastatic or recurrent site (specimen from distant metastatic site and/or specimen from locoregional recurrent site) can be submitted.
Key exclusion criteria
"1) Patients with active multiple cancers at the time of diagnosis of invasive breast cancer
2) Patients judged by the principal investigator or subinvestigator to be inappropriate for this study"
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Imoto |
Organization
Kyorin University
Division name
School of Medicine, Department of Breast Surgery
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-shi, TOKYO 181-8611 JAPAN
TEL
0422-47-5511
imoto@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigeru |
| Middle name | |
| Last name | Imoto |
Organization
Japanese Foundation for Multidisciplinary Treatment of Cancer
Division name
Office
Zip code
136-0071
Address
1-38-4, kameido, koto-ku, Tokyo, 136-0071 Japan
TEL
03-5627-7594
Homepage URL
jfmc52@jfmc.or.jp
Sponsor or person
Institute
Japanese Foundation for Multidisciplinary Treatment of Cancer
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO COMPANY, LIMITED
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
Nippon Medical School Foundation Central Ethics Commission
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel
03-3822-2131
chuorinri.group@nms.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
| 2025 | Year | 02 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 02 | Month | 19 | Day |
Last modified on
| 2025 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065145
