UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015049 |
|---|---|
| Receipt number | R000017483 |
| Scientific Title | Phase 2 trial of eribulin/S-1 combination therapy for advanced/recurrent breast cancer |
| Date of disclosure of the study information | 2014/09/05 |
| Last modified on | 2016/06/02 13:15:10 |
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Basic information
Public title
Phase 2 trial of eribulin/S-1 combination therapy for advanced/recurrent breast cancer
Acronym
ERIS-Study
Scientific Title
Phase 2 trial of eribulin/S-1 combination therapy for advanced/recurrent breast cancer
Scientific Title:Acronym
ERIS-Study
Region
| Japan |
Condition
Condition
Advanced and recurrent breast cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of eribulin/S-1 combination therapy for HER2 negative, advanced/recurrent breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Overall response rate
Key secondary outcomes
Safety, Duration of response, Progression free survival, Disease control rate, Clinical benefit rate, Overall survival, New metastasis-free survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Combination therapy of Eribulin and S-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
1.histlogically or cytologically confirmed breast cancer
2.patients with unresectable stage 3C or 4
3.patients with history of prior treatment with anthracycline and taxane as pre/post-operative treatment or treatment to prevent recurrence.
4.HER2 negative
5.patients previously treated with no more than 2 chemotherapy regimen for recurrent/metastasis breast cancer
6.patients with more than one of the following
(1)ER negative (<10%)
(2)internal metastasis
(3)more than 3 metastatic sites
(4)DFI<= 2years
7.patients at least 20 years of age but not older than 75 at the time of informed
8.ECOG performance status 0-1
9.patients with evaluable lesion(identified within 28 days before the entry) by RECIST 1.1 criteria
10.Required baseline laboratory parameters (within 14 days before the entry)
neutrophil >=1,500/mm3
Plt >=100,000/mm3
Hb >=9.0g/dL
AST and ALT <=100IU/L,
(AST and ALT<=150IU/L, if patients have liver metastasis)
total bilirubin <=1.5mg/dL
creatinine clearance <=60 ml/min
11.no carry-over effect or side effect that could affect the study outcome of prior treatment
washout period;
1) >=4weeks: antibody-drug, chemotherapy,operative treatment
2) >=2weeks:radiotherapy, endocrine therapy, immunotherapy, oral fluoride pyrimidine-based drug, molecular target drug, blood transfusion, blood products, G-CSF
12.written informed consent was obtained
13.with life expectancy greater than 3 months.
Key exclusion criteria
1.patients with history of prior treatment with eribulin and S1
2.patients with infection or HBs antigen positive
3.pleural effusion, peritoneal effusion which needs drainage
4.brain metastasis with clinical symptoms
5.patients with following serious complication
(1)ischemic heart disease and arrhythmic cardiac disease with poor control.
(2)ischemic heart disease within 6 months,
(3)liver cirrhosis,
(4)watery diarrhea
(5)interstitial pneumonia or pulmonary fibrosis by chest radiograph
(6)bleeding tendency
(7)another serious complication
6.patients with active double cancer
7.patients who need to receive continuous corticosteroid administration
8.patients with a history of widespread radiation therapy
9.pregnant or nursing women
10.patients with serious drug allergy
11.patients who are participating in the other clinical trial
12.patients judged improper to entry this trial by physician
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junji Tsurutani |
Organization
Kindai University Hospital, Faculty of medicine
Division name
Department of medical oncology
Zip code
Address
377-2 Ohnohigashi, Osakasayama City, Osaka, Japan
TEL
072-366-0221
tsurutani_j@dotd.med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Advanced Clinical Research Organization |
Organization
Advanced Clinical Research Organization
Division name
ERIS STUDY OFFICE
Zip code
Address
4F Hoei Fuchu Bulding,2-10-3 Kotobukicho, Fuchu-shi,Tokyo
TEL
042-352-7676
Homepage URL
eris-study@npo-acro.jp
Sponsor or person
Institute
Advanced Clinical Research Organization
Institute
Department
Personal name
Funding Source
Organization
Eisai
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 09 | Month | 05 | 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
| 2014 | Year | 08 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 04 | Day |
Last modified on
| 2016 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017483
