UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046521 |
|---|---|
| Receipt number | R000053078 |
| Scientific Title | A retrospective analysis of TP53 signature for predicting treatment response and prognosis in breast cancer |
| Date of disclosure of the study information | 2022/01/04 |
| Last modified on | 2025/07/08 22:28:52 |
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Basic information
Public title
A retrospective analysis of TP53 signature for predicting treatment response and prognosis in breast cancer
Acronym
A retrospective analysis of TP53 signature
Scientific Title
A retrospective analysis of TP53 signature for predicting treatment response and prognosis in breast cancer
Scientific Title:Acronym
A retrospective analysis of TP53 signature
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the predictive and prognostic value of TP53 signature in a cohort of breast cancer patients who received preoperative chemotherapy, which is registered and available in a public database.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pathological complete response
Key secondary outcomes
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
| 99 | years-old | >= |
Gender
Female
Key inclusion criteria
T1-3,N0-1,M0 breast cancer
Key exclusion criteria
Cases with unreliable gene expression data
Target sample size
740
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Takahashi |
Organization
Tohoku University Hospital
Division name
Department of Medical Oncology
Zip code
980-9575
Address
4-1, Seiryo-machi, Aobaku, Sendai
TEL
022-717-8543
shin.takahashi.e7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Takahashi |
Organization
Tohoku University Hospital
Division name
Department of Medical Oncology
Zip code
980-9575
Address
4-1, Seiryo-machi, Aobaku, Sendai
TEL
022-717-8543
Homepage URL
shin.takahashi.e7@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Graduate School of Medicine, Tohoku University
Address
1-1, Seiryo-machi, Aobaku, Sendai
Tel
022-728-4105
med-kenkyo@grp.tohoku.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 | 01 | Month | 04 | Day |
Related information
URL releasing protocol
https://journals.sagepub.com/doi/10.1177/11782234231167655
Publication of results
Published
Result
URL related to results and publications
https://journals.sagepub.com/doi/10.1177/11782234231167655
Number of participants that the trial has enrolled
740
Results
The TP53 mutant signature was significantly associated with higher pathological complete response (pCR) rates following neoadjuvant chemotherapy (NAC).
Patients with RD and a TP53 mutant signature had significantly worse prognosis compared to those with wild-type signature or pCR.
Combining TP53 signature and pathological response effectively stratifies patients into prognostic subgroups.
Results date posted
| 2025 | Year | 07 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study included 333 patients with HER2-negative breast cancer (clinical stage T1-3/N0-1) who received taxane and anthracycline-based NAC.
The median age was 49 years (range 24-75).
Participant flow
Data were obtained retrospectively from public microarray datasets: GSE25066 (main cohort), and GSE20194, GSE20271, GSE32603, GSE140494 (validation cohorts).
Patients with HER2-negative, T1-3/N0-1 breast cancer who received NAC were selected from these datasets.
Adverse events
not applicable
Outcome measures
Primary endpoints:
Predictive value of the TP53 signature for pCR (evaluated by odds ratio, sensitivity, specificity, PPV, NPV).
Prognostic value of TP53 signature and other clinicopathological factors in RD patients (analyzed via Cox regression for DRFS).
Secondary analyses:
Stratified analysis in ER-positive and TNBC subgroups.
Validation in four independent cohorts.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To verify the difference of patological complete response (pCR) between mutant type and wild type of TP53 signature using Fisher's exact test. Performance of TP53 signature against pCR will be evaluated using sensitivity, specificity, positive predictive value, and negative predictive value. Recurrence-free survival will be estimated using the Kaplan-Meier method, and the log-rank test will be used to test whether recurrence-free survival is different between mutant and wild types of TP53 signature.
Management information
Registered date
| 2022 | Year | 01 | Month | 02 | Day |
Last modified on
| 2025 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053078
