UMIN-CTR Clinical Trial

Public title

Phase II clinical study of eribulin monotherapy in Japanese patients with metastatic breast cancer who presented well-defined taxane resistance

Acronym

Phase II clinical study of eribulin monotherapy in Japanese patients with metastatic breast cancer who presented well-defined taxane resistance

Scientific Title

Phase II clinical study of eribulin monotherapy in Japanese patients with metastatic breast cancer who presented well-defined taxane resistance

Scientific Title:Acronym

Phase II clinical study of eribulin monotherapy in Japanese patients with metastatic breast cancer who presented well-defined taxane resistance

Region

Japan

Condition

Breast Cancer

Classification by specialty

Hematology and clinical oncology

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate efficacy and safety of Eribulin in patients with Taxane-resisted Metastatic breast cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Clinical Benefit Rate

Key secondary outcomes

EORTC QLQ-C30
Progression Free Survival
Overall Survival
Safety

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

1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.

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

75

years-old

>=

Gender

Female

Key inclusion criteria

1)female patient who were histologically or cytologically confirmed as breast cancer
2)previously treated with chemotherapeutic regimens including an anthracycline and a taxane:
relapse during or within a year after neoadjuvant or post-operative adjuvant chemothrapy
with a taxane immediately before the study
progression during chemothrapy with a taxane in the metastatic setting
3)aged more than 20years and less than 75 years
4)ECOG PS of 0-2
5)having measurable lesion according to RECIST
6)adequate organ functions confirmed with following major examination:
neutrophil count more than 1500/microl
platelet count more than 100,000/microl
hemoglobin more than 8.0g/dL
AST,ALT less than 2.5 times the upper limit of nomal (ULN)
total bilirubin less than 1.5 times the upper limit of nomal (ULN)
serum creatinine less than 1.5 times the upper llimit of nomal (ULN)
7)obtained written informed consent

Key exclusion criteria

1)having systemic infection with a fever of 38 degrees or more
2)pleural effusion, ascites, or pericardial fluid requiring drainage
3)brain metastasis with clinical symptoms
4)patient with following serious complication
ischaemic heart disease or heart disease such as arrhythmia not controllable by treatment
myocardial infarction < 6 months prior to study entry
hepatic cirrhosis
interstitial pneumonia or pulmonary fibrosis
bleeding tendency
5)having active double cancer
6)HER2 over-expressed
7)pregnancy, breast-feeding or women with childbearing potential
8)judged by the investigator not to be appropriate for the study

Target sample size

52

Name of lead principal investigator

1st name
Middle name
Last name	Kenichi Inoue

Organization

Saitama Cancer Center

Division name

Division of Breast Oncology

Zip code

Address

780 Komuro, Ina-machi, Kita-Adachi-gun, Saitama, Japan

TEL

048-722-1111

Email

ino@cancer-c.pref.saitama.jp

Name of contact person

1st name
Middle name
Last name	Toshihiro Kai

Organization

Saitama Breast Cancer Clinical Study Group (SBCCSG)

Division name

Secretariat Division (Shintoshin Ladies' Mammo Clinic)

Zip code

Address

3F Capital Building ,4-261-1 kishiki-cho, omiya-ku, saitama-shi

TEL

048-600-1722

Homepage URL

http://www.sbccsg.org/

Email

toshikai@sbccsg.org

Institute

Saitama Breast Cancer Clinical Study Group (SBCCSG)

Institute

Department

Personal name

Organization

Saitama Breast Cancer Clinical Study Group (SBCCSG)

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

埼玉県立がんセンター，さいたま赤十字病院，自治医大さいたま医療センター，埼玉社会保険病院，赤心堂病院，春日部市立病院

Date of disclosure of the study information

2012

Year

01

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2011

Year

11

Month

17

Day

Date of IRB

Anticipated trial start date

2012

Year

01

Month

01

Day

Last follow-up date

2016

Year

11

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

12

Month

27

Day

Last modified on

2017

Year

11

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008225