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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041711
Receipt No. 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 2020/09/07

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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
Email 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
Email taqnakayama@hotmail.com

Sponsor
Institute The Supporting Center for Clinical Research and Education
Institute
Department

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
Email 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)

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 Preinitiation
Date of protocol fixation
2020 Year 08 Month 18 Day
Date of IRB
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
2020 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047604

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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