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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name