UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051581 |
|---|---|
| Receipt number | R000058542 |
| Scientific Title | Cohort Study to Evaluate the Efficacy and Safety of Postoperative Adjuvant Therapy in HER2 Positive Elderly Breast Cancer Patients with Muti-gene assay |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2023/08/07 20:56:04 |
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Basic information
Public title
Cohort Study to Evaluate the Efficacy and Safety of Postoperative Adjuvant Therapy in HER2 Positive Elderly Breast Cancer Patients with Muti-gene assay
Acronym
Trans-RESPECT
Scientific Title
Cohort Study to Evaluate the Efficacy and Safety of Postoperative Adjuvant Therapy in HER2 Positive Elderly Breast Cancer Patients with Muti-gene assay
Scientific Title:Acronym
N-SAS BC07 biomarker study (Trans-RESPECT)
Region
| Japan |
Condition
Condition
HER2 Positive Elderly Breast Cancer Patients
Classification by specialty
| Breast surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
1) Examine the effective population for trastuzumab monotherapy by risk classification by HER2DX.
2) Compare the risk classification by HER2DX of trastuzumab monotherapy versus combination therapy with chemotherapy.
3) Evaluate the benefit of HER2DX for patients over 70 years of age.
4) Evaluate the overall survival of trastuzumab alone versus in combination with chemotherapy for patients 70 and older.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Recurrence-free survival in the trastuzumab monotherapy group
Key secondary outcomes
Overall Survival, Disease-Free Survival, Breast cancer-specific survival, RFS for trastuzumab alone and in combination with chemotherapy
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
| 70 | years-old | <= |
Age-upper limit
| 81 | years-old | > |
Gender
Female
Key inclusion criteria
1) FAS of the N-SAS BC 07 RCT for the period October 2009 to November 2014
2) Consent to participate in the study has been obtained from the patients themselves via a consent form
Key exclusion criteria
Patient's physician determines that the patient is inappropriate to participate in this clinical trial
Target sample size
266
Research contact person
Name of lead principal investigator
| 1st name | Masataka |
| Middle name | |
| Last name | Sawaki |
Organization
Aichi Cancer Center Hospital
Division name
Department of Breast Oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku Nagoya, Japan
TEL
0527626111
m-sawaki@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Nozawa |
Organization
Aichi Cancer Center Hospital
Division name
Department of Breast Oncology
Zip code
4648681
Address
1-1 Kanokoden, Chikusa-ku Nagoya, Japan
TEL
0527626111
Homepage URL
k.nozawa@aichi-cc.jp
Sponsor or person
Institute
Public Health Research Foundation
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
CHUGAI PHARMACEUTICAL CO.
REVEAL GENOMICS, S.L.
Name of secondary funder(s)
REVEAL GENOMICS, S.L.
IRB Contact (For public release)
Organization
Aichi Cancer Center Hospital
Address
1-1 Kanokoden, Chikusa-ku Nagoya, Japan
Tel
0527626111
irb-jimu@aichi-cc.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 | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2023 | Year | 07 | Month | 11 | Day |
Last modified on
| 2023 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058542
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
