UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050326 |
|---|---|
| Receipt number | R000057285 |
| Scientific Title | Cohort study of treatment strategy for low risk HER2 positive breast cancer based on response-guided therapy and shared decision making |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2023/04/23 16:37:55 |
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Basic information
Public title
Cohort study of treatment strategy for low risk HER2 positive breast cancer based on response-guided therapy and shared decision making
Acronym
HERREST study
Scientific Title
Cohort study of treatment strategy for low risk HER2 positive breast cancer based on response-guided therapy and shared decision making
Scientific Title:Acronym
HERREST study
Region
| Japan |
Condition
Condition
HER2 positive breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective is to evaluate whether choosing treatment through Response-guided therapy for low-risk HER2 positive breast cancer patients with tumor size of 1-3 cm leads to a reduction in side effects and improvement in prognosis. Additionally, it aims to evaluate whether the choice of treatment based on Shared decision making improves the satisfaction of medical staff and patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Disease-free survival for all prospective study subjects
Key secondary outcomes
Pathological evaluation by each subgroup
OS for all prospective study subjects
DFS,OS for each subgroup
Final percentage of patients who did not receive EC
Adverse events overall and by each subgroup
Treatment response of each regimen
Clinical response especially for taxane and anti-HER2 therapy
Actual results of SDM and the reasons for their decisions
Patient and medical staff with the process of response-guided therapy
Qualitative evaluation of SDM in response-guided 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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Histologically diagnosed invasive cancer that has not been treated in any way
2) 1cm =<cT =< 3cm, cN0
3) Women between 20 and 80 years of age
4) HER2 positive breast cancer IHC 3 plus or FISH amplification
5) The latest laboratory values within 4 weeks prior to enrollment meet all of the following
1 Neutrophil count >=1500/mm3 or white blood cell count >= 3000/mm3
2 Hemoglobin >= 8.0 g/dl
3 Platelet count >=100000/mm3
4 Total bilirubin =< less than twice the institutional standard
5 AST or ALT =< 2.5 times or less than the institutional standard
6 Creatinine =< 2.0 mg/dL
6) Left ventricular ejection fraction >50% on the most recent echocardiography
7) PS, 0-2
Key exclusion criteria
1) Concurrent bilateral breast cancer, multiple ipsilateral breast cancers of different subtypes
2) History of breast cancer, active overlapping cancers, history of allergies that would result in protocol interruption
3) History of serious cardiac disease (heart failure, myocardial infarction, ischemic disease, vascular disease requiring treatment)
4) Difficulty in continuing hospital visits due to physical inactivity
5) Complicated mental illness or psychiatric symptoms that make participation in the study difficult
6) In case the attending physician determines that the subject is not suitable for participation in the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Shiba |
Organization
Osaka Breast Clinic
Division name
Department of Breast and Endocrine Surgery
Zip code
553-0007
Address
1-13-8 Ohiraki, Fukushima, Osaka City, Osaka
TEL
06-6465-4108
eshiba@goo.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Fujita |
Organization
Osaka Breast Clinic
Division name
Department of Breast and Endocrine Surgery
Zip code
553-0007
Address
1-13-8 Ohiraki, Fukushima, Osaka City, Osaka
TEL
06-6465-4108
Homepage URL
noriko_f_0505@yahoo.co.jp
Sponsor or person
Institute
Eiichi Shiba,the Department of Breast and Endocrine Surgery, Osaka Breast Clinic
Institute
Department
Personal name
Funding Source
Organization
Osaka Breast Clinic
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Breast Clinic
Address
1-13-8 Ohiraki, Fukushima, Osaka City, Osaka
Tel
06-6465-4108
noriko_f_0505@yahoo.co.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 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2033 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research Methodology Overview
Prospective study
Enrollment period: 5 years from February 13, 2023.
Follow-up period: 5 years after the last case enrollment.
Study period: 12 years from February 13, 2023.
Retrospective study
Enrollment period: from September 1, 2006 to the last enrollment.
Follow-up period: 5 years after the last enrollment.
(1) Survival curves using the Kaplan-Meier method and recurrence-free survival and overall survival rates will be calculated for all patients in the prospective study and for DFS and OS in each subgroup. The results will be compared among retrospective studies, previously reported results, and each subgroup.
(2) The percentage of satisfaction with response-guided therapy will be evaluated at four points (preoperative, 1 year postoperative, 3 years postoperative, and 5 years postoperative) to investigate the change over time in the percentage of satisfaction with each question on the part of both providers and patients.
(3) The quality of SDM will be evaluated using the SDM-Q-9/SDM-Q-Doc before and 1 year after surgery.
Management information
Registered date
| 2023 | Year | 02 | Month | 13 | Day |
Last modified on
| 2023 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057285
