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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040260
Receipt No. 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

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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
Email 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
Email kkosuke@kuhp.kyoto-u.ac.jp

Sponsor
Institute Japan Breast Cancer Research Group
Institute
Department

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
Email 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
URL(English) https://upload.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


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