UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041711 |
|---|---|
| Receipt number | R000047604 |
| Scientific Title | Prospective observational study to evaluate predictive factor for efficacy of Eribulin(KBCSG-TR2018) |
| Date of disclosure of the study information | 2020/09/08 |
| Last modified on | 2023/03/10 10:07:49 |
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Basic information
Public title
Prospective observational study to evaluate predictive factor for efficacy of Eribulin(KBCSG-TR2018)
Acronym
POTENTIAL
Scientific Title
Prospective observational study to evaluate predictive factor for efficacy of Eribulin(KBCSG-TR2018)
Scientific Title:Acronym
POTENTIAL
Region
| Japan |
Condition
Condition
HER2-negative
advanced or metastatic breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the potential mechanism of action of eribulin by analizing the relationship between the variations of blood biomarkers and clinical outcomes including improved overall survival, inhibition of new metastases, etc. in eribulin-treated patients, as well as to explore new biomarkers identifying the population for eribulin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between changes in TGF-beta after administration of Eribulin and the following clinical outcomes.
･Objective Response Rate(ORR)
･Time to Treatment Failure(TTF)
･new Metastasis-Free Survival(nMFS)
･Overall Survival:OS
･Time to Treatment Failure of post treatment
Key secondary outcomes
･Effect of eribulin on the level of immune related cytokines/chemokines, angiogenesis-related proteins, and Treg.
･Correlation between baseline ALC and clinical outcomes (ORR, TTF, nMFS, OS, and TTF of post-treatment).
･Correlation between blood biomarker and clinical outcomes.
･Adverse events (Grade3 or higher) and serious adverse events.
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
| Not applicable |
Gender
Female
Key inclusion criteria
1) Confirmed diagnosis of advanced or recurrent breast cancer
2) HER2 negative
3) Age >=20 years at the time of informed consent
4) <=2 prior chemotherapy for advanced or recurrent disease
5) ECOG performance status score of 0 or 1
6) Life expectancy of >= 6 months
7) Scheduled to receive monotherapy of eribulin, weekly paclitaxel, capecitabine, S-1 or combination therapy of weekly paclitaxel and bevacizumab
Key exclusion criteria
1) >=3 prior chemotherapy for advanced or recurrent disease
2) Previous treatment with eribulin
3) The patient who needs the dosage of a steroid and/or immunosuppressive drug except for a purpose of the pre-medication for chemotherapy
4) Patients who are determined to be inappropriate to participate in this study by the investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Nakayama |
Organization
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Division name
Department of breast and endocrine surgery
Zip code
541-8567
Address
3-1-69 Otemae, Chuo-ku, Osaka
TEL
06-6945-1181
taqnakayama@hotmail.com
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Nakayama |
Organization
NPO the SupportingCenter for Clinical Research and Education
Division name
Kinki Breast Cnacer Study Group-Translational Research
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka
TEL
06-6897-5037
Homepage URL
taqnakayama@hotmail.com
Sponsor or person
Institute
The Supporting Center for Clinical Research and Education
Institute
Department
Personal name
Funding Source
Organization
Eisai Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Eisai Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Address
3-1-69 Otemae, Chuo-ku, Osaka
Tel
06-6945-1181
rinri01@opho.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
大阪国際がんセンター（大阪府）兵庫医科大学病院（兵庫県）、大阪医療センター（大阪府）
大阪大学医学部附属病院（大阪府）、八尾市立病院（大阪府）、市立貝塚病院（大阪府）
北海道がんセンター（北海道）、大阪労災病院（大阪府）、大阪警察病院（大阪府）、
筑波大学附属病院（茨城県）、関西労災病院（兵庫県）、JCHO大阪病院（大阪府）、
広島市立広島市民病院（広島県）、大阪赤十字病院（大阪府）、松山赤十字病院（愛媛県）
神奈川県立がんセンター（神奈川県）、うえお乳腺外科（大分県）、さいたま赤十字（埼玉県）、
近畿大学病院（大阪府）、都立駒込病院（東京都）、関西メディカル病院（大阪府）、
九州がんセンター（福岡県）、大阪ブレストクリニック（大阪府）、昭和大学病院（東京都）、
国立がん研究センター東病院（千葉県）、東北大学病院（宮城県）、静岡県立総合病院（静岡県）、
弘前市立病院（青森県）、埼玉県立がんセンター（埼玉県）、大阪市立大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 08 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study,
Condition:HER2-negative advanced or metastatic breast cancer
Recruitment method: Patients who meet the selection criteria and consented to participate in this study at the facility conducting this study.
Management information
Registered date
| 2020 | Year | 09 | Month | 07 | Day |
Last modified on
| 2023 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047604
| Research Plan | |
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| 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 |
