UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040260 |
|---|---|
| Receipt number | R000045350 |
| Scientific Title | Predictive biomarkers for capecitabine benefit in breast cancer patients with residual disease after neoadjuvant chemotherapy |
| Date of disclosure of the study information | 2020/04/28 |
| Last modified on | 2021/08/27 13:30:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Predictive biomarkers for capecitabine benefit in breast cancer patients with residual disease after neoadjuvant chemotherapy
Acronym
JBCRG-04(CREATE-X) TR
Scientific Title
Predictive biomarkers for capecitabine benefit in breast cancer patients with residual disease after neoadjuvant chemotherapy
Scientific Title:Acronym
JBCRG-04(CREATE-X) TR
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify predictive biomarkers for capecitabine benefit in breast cancer patients with residual disease after neoadjuvant chemotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between tumor immune microenvironment and 1)-6)
1) Patient characteristics, Pathological signature such as ER, HER2 status.
2) Disease free survival
3) Overall survival
4) Incidence of local recurrence
5) Incidence of distant metastasis
6) Clinical response rate of neoadjuvant chemotherapy
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
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
Patients who were registered A phase III randomized study of capecitabine as adjuvant chemotherapy versus observation in breast cancer with pathologic residual tumors after preoperative chemotherapy (JBCRG-04) trial
Key exclusion criteria
This study is a retrospective observational study, carried out by the opt-out method of our website.
Target sample size
606
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Toi |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of breast surgery
Zip code
6068507
Address
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto 606-8507, JAPAN
TEL
075-751-3660
toi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Kawaguchi |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of breast surgery
Zip code
6068507
Address
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto 606-8507, JAPAN
TEL
075-751-3660
Homepage URL
kkosuke@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Japan Breast Cancer Research Group
Institute
Department
Personal name
Funding Source
Organization
Japan Breast Cancer Research Group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
N/A
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
| 2020 | Year | 04 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Translational research of the JBCRG-04 (CREATE-X) trial (UMIN000000843)
Management information
Registered date
| 2020 | Year | 04 | Month | 28 | Day |
Last modified on
| 2021 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045350
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
