UMIN-CTR Clinical Trial

Public title

Study to evaluate the bi-weekly schedule of eribulin for patients with advanced or reccurent breast cancer

Acronym

Study to evaluate the bi-weekly schedule of eribulin for patients with advanced or reccurent breast cancer

Scientific Title

Study to evaluate the bi-weekly schedule of eribulin for patients with advanced or reccurent breast cancer

Scientific Title:Acronym

Study to evaluate the bi-weekly schedule of eribulin for patients with advanced or reccurent breast cancer

Region

Japan

Condition

advanced or reccurent breast cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the benefit of bi-weekly schedule of eribulin for patients with advanced or reccurent breast cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Primary outcomes

Time to treatment failure
Dose intensity(mg/m2/week)

Key secondary outcomes

Overall response rate
Progression free survival
Clinical benefit rate
Safety(AE)
Dose

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

One cycle consists of 4 weeks.
Eribulin will be administrated intravenously on day1 and 15.
Administration can be continued until the evidence of desease progression or unacceptable toxcity.

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

1)Administrated 1.4mg/m2 on day1 and skipped on day8 due to administration criteria
2)Satisfied administration criteria on day15
3)Female with hisitologically or citologically confirmed breast cancer
4)Aged 20-years when giving informed consent
5)ECOG perfomance status(PS) 0-2
6)With measurable lesion met the RECIST criteria and evaluated baseline within 30days before Eribulin first treatment
7)Have received anthracycline and taxan
8)Have no carryover of efficacy or no adverse drug reactions from previous therapy
9)With adequate function of major organs
10)With an expected survival of >= 3 months from Eribulin first treatment
11)Planed with eribulin monotherapy
12)Have given wriiten voluntary concent for participation in this study

Key exclusion criteria

1)Systemic infection
2)Dirrea, ileus
3)GI bleeding
4)Sever drug allergy
5)Sever renal and/or liver disfunction
6)Significant interstitial pneumonia or plumonary fibrosis by chest X-P
7)Pleural effusion, peritoneal effusion
8)Uncontrolled hypertension or diabetes mellitus
9)Maintenance therapy with systemic corticosteroids
10)Pregnant women or women with suspected pregnancy
11)Active double cancer
12)Severe psychiatric disorder
13)Active brain metastases
14)Participating in other chemotherapy or study
15) Judeged by the investigator to be unfit for this study

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Kazutaka Narui

Organization

Yokohama City University Medical Center

Division name

Breast and thyroid surgery

Zip code

Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Email

nr1@gc5.so-net.ne.jp

Name of contact person

1st name
Middle name
Last name	Kazutaka Narui

Organization

Yokohama City University Medical Center

Division name

Breast and thyroid surgery

Zip code

Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Homepage URL

Email

nr1@gc5.so-net.ne.jp

Institute

Yokohama City University Medical Center

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

10

Month

11

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www2.convention.co.jp/25jbcs/

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

08

Month

08

Day

Date of IRB

Anticipated trial start date

2012

Year

10

Month

11

Day

Last follow-up date

2017

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

10

Month

11

Day

Last modified on

2018

Year

04

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010659