UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055735 |
|---|---|
| Receipt number | R000063692 |
| Scientific Title | Personalized Detection of ctDNA for Patients with HER2 Positive Metastatic Breast Cancer who Achieved Durable Response by Anti-HER2 Treatment |
| Date of disclosure of the study information | 2024/10/03 |
| Last modified on | 2025/10/06 13:23:27 |
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Basic information
Public title
A cohort study using ctDNA for HER2-positive breast cancer with sustained therapeutic effects from anti-HER2 treatment
Acronym
HER2CR
Scientific Title
Personalized Detection of ctDNA for Patients with HER2 Positive Metastatic Breast Cancer who Achieved Durable Response by Anti-HER2 Treatment
Scientific Title:Acronym
HER2CR
Region
| Japan |
Condition
Condition
HER2-positive metastatic breast cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the utility of ctDNA monitoring in HER2-positive metastatic recurrent breast cancer that has achieved long-term response through anti-HER2 therapy.
Basic objectives2
Others
Basic objectives -Others
To analyze the relationship between ctDNA status, treatment outcomes, and clinicopathological factors.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
The positivity rate of ctDNA
Key secondary outcomes
Association between ctDNA status and treatment response
Comparison between ctDNA-negative and ctDNA-positive groups
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
Histologically invasive breast cancer.
Diagnosed with unresectable HER2-positive breast cancer
Drug therapy, including anti-HER2 therapy, was initiated between January 1, 2000, and December 31, 2021.
Maintained partial or complete response for more than two years with drug therapy, including anti-HER2 therapy.
Women aged 20 years or older.
Key exclusion criteria
Patients deemed unsuitable as research subjects by the physicians' judgment, such as those possibly receiving inappropriate treatment.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Nozawa |
Organization
Nagoya City University
Division name
Department of Advanced Clinical Research and Development
Zip code
4678601
Address
1,Kawasumi, Mizuho-cho, Mizuho-ku Nagoya 467-8601, Japan
TEL
0528538628
kazuki.nozawa7@gmail.com
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Nozawa |
Organization
Nagoya City University
Division name
Department of Advanced Clinical Research and Development
Zip code
4678601
Address
1,Kawasumi, Mizuho-cho, Mizuho-ku Nagoya 467-8601, Japan
TEL
0528538628
Homepage URL
kazuki.nozawa7@gmail.com
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
No funding source
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Natera
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Address
3-8-31 Ariake, Kotou-ku, Tokyo, Japan
Tel
03-3520-0111
kazuki.nozawa7@gmail.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort study
Management information
Registered date
| 2024 | Year | 10 | Month | 03 | Day |
Last modified on
| 2025 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063692
