UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000027527
Receipt number	R000031554
Scientific Title	Exploratory clinical study of eribulin followed by taxane for metastatic breast cancer patients
Date of disclosure of the study information	2017/05/29
Last modified on	2019/05/31 11:27:54

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Basic information

Public title

Exploratory clinical study of eribulin followed by taxane for metastatic breast cancer patients

Acronym

Exploratory clinical study of eribulin followed by taxane for metastatic breast cancer patients.

Scientific Title

Exploratory clinical study of eribulin followed by taxane for metastatic breast cancer patients

Scientific Title:Acronym

Exploratory clinical study of eribulin followed by taxane for metastatic breast cancer patients.

Region

Japan

Condition

Metastatic breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

To evaluate efficacy of eribulin followed by taxane in patients with metastatic breast cancer.
(Comparison of literature data)

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

TTP(Time to progression) of taxane after administration of eribulin.
(Comparison of literature data)

Key secondary outcomes

Base

Study type

Interventional

Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients of administerd taxane after eribulin in 1st or 2nd line chemotherapy for metastatic breast cancer.

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

80 years-old >

Gender

Female

Key inclusion criteria

1)metastatic breast cancer(HER2-)
2)ECOG performance status 0-1
3)The presence of at least one measurable lesion
4)The patients with the measurable lesion by RECIST1.1
5)The patients of eribulin followed by taxane
6)The patients with adequate organ function
neutrophil count>1000
Platelet count>75,000
Hemoglobin>9.0
AST/ALT<=75
Total bilirubin<1.5
Serum creatinine<1.5

7)Age>=20years,<80years
8)Written informed concent

Key exclusion criteria

1)HER2+
2)Concurrent active infections
3)The presence of brain metastasis requiring treatment
4)Sever complications
Current uncontorolled CHF
History of myocardial infractionwithin 6 months of randomization
Cirrhosis of the liver
Interstitial pneumonaitis
Hemorrhagic Diathesis
5)Patients with synchronous double cancer
6)Pregnant or nursing women or who suspected pregnant
7)The patients combination has been chemotherapy,immunotherapy,hormone therapy,radiation therapy and surgical treatment
8)Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol

Target sample size

Research contact person

Name of lead principal investigator

1st name Hiroaki

Middle name

Last name Nagano

Organization

Yamaguchi University Graduate School of Medicine

Division name

Department of Gastroenterological, Breast and Endocrine Surgery

Zip code

755-8505

Address

1-1-1Minamikogushi,Ube,Yamaguchi 755-8505 Japan

TEL

083-622-2264

Email

hnagano@yamaguchi-u.ac.jp

Public contact

Name of contact person

1st name Noriko

Middle name

Last name Maeda

Organization

Yamaguchi University Graduate School of Medicine

Division name

Department of Gastroenterological, Breast and Endocrine Surgery

Zip code

755-8505

Address

1-1-1Minamikogushi,Ube,Yamaguchi 755-8505 Japan

TEL

083-622-2264

Homepage URL

Email

nsampei@yamaguchi-u.ac.jp

Sponsor or person

Institute

Yamaguchi University Graduate School of Medicine

Institute

Department

Personal name

Funding Source

Organization

None

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

Yamaguchi University Graduate School of Medicine

Address

1-1-1Minamikogushi,Ube,Yamaguchi 755-8505 Japan

Tel

0836-22-2428

Email

clin_res@yamaguchi-u.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2017 Year 05 Month 29 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

Open public recruiting

Date of protocol fixation

2017 Year 05 Month 02 Day

Date of IRB

Anticipated trial start date

2017 Year 05 Month 29 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2017 Year 05 Month 29 Day

Last modified on

2019 Year 05 Month 31 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031554

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name