UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021585
Receipt number R000024896
Scientific Title A phase II study of eribulin in combination with trastuzumab and pertuzumab as First-Line therapy for metastatic HER2-positive breast cancer
Date of disclosure of the study information 2016/03/23
Last modified on 2021/03/27 14:46:45

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Basic information

Public title

A phase II study of eribulin in combination with trastuzumab and pertuzumab as First-Line therapy for metastatic HER2-positive breast cancer

Acronym

SBCCSG-36

Scientific Title

A phase II study of eribulin in combination with trastuzumab and pertuzumab as First-Line therapy for metastatic HER2-positive breast cancer

Scientific Title:Acronym

SBCCSG-36

Region

Japan


Condition

Condition

First-Line therapy for metastatic HER2-positive breast cancer.

Classification by specialty

Hematology and clinical oncology Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the usefulness of eribulin in combination with trastuzumab and pertuzumab as first line therapy for patients with metastatic HER2-positive breast cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

time to chemotherapy treatment failure of response rate

Key secondary outcomes

time to chemotherapy treatment failure, progression free survival, response rate, overall survival, safety


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

Administration of eribulin,trastuzumab, and pertuzumab every three weeks until disease progression or occurring adverse events difficult to continue.

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1.Histologically confirmed primary breast cancer
2.Age of 18 years and expected survival is more than 6months
3.Histologically confirmed HER2-positive breast cancer in primary lesion or metastatic lesion(Score 3+ by IHC or HER2 Positive by FISH or DISH)
4.First line therapy of Stage IIIB,IIIC,IV or recurrent breast cancer
5.ECOG performance status(PS) 0 or 1(Allow PS 2 due to bone metastases)
6.Clinically confirmed measurable or unmeasurable metastatic lesion except ascites or effusion alone
7.Adequate organ function shown in physical examinations within 14 days prior to enrollment
Neutrophil count >=1500/mm3
Platelet count >=75,000/mm3
Hemoglobin >=9.0g/dL
Total serum bilirubin <=2.0mg/dL
AST and ALT <100IU/L
Serum creatinine <=1.5mg/dL
8.No clinical electrocardiographic abnormality
9.Echocardiographic ejection fraction >=55%
10.Subjects who have submitted written informed consent for study entry

Key exclusion criteria

1.Active infection or fever at risk of infection
2.History of serious drug allergies
3.Spontanous serious renal damage or liver dysfunction(jaundice)
4.Large pleural effusion or ascites requiring repeat drainage
5.Systemic administration of steroid drug
6.Pregnant females or females of child-bearing potential
7.Concurrent active other malignancy
8.Metachronous or spontaneous bilateral breast cancer except ductal carcinoma in situ
9.Clinically important mental disorder or history of central nervous system damage
10.Clinically significant central nervous system metastases
11.Concurrent enrollment of other clinical trial
12.Reccurence in conserving breast or local recurrence that is appropriate therapy to reoperate
13.HBs antigen positive
14.Not suitable for participation with any other reasons
(including rapid progression disease, life threatening status if not successfully treated)

Target sample size

16


Research contact person

Name of lead principal investigator

1st name Kenichi
Middle name
Last name Inoue

Organization

Saitama Cancer Center

Division name

Division of Breast Oncology

Zip code

3620806

Address

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

TEL

048-722-1111

Email

ino@cancer-c.pref.saitama.jp


Public contact

Name of contact person

1st name Jun
Middle name
Last name Ninomiya

Organization

Sairtama Breast Cancer Clinical Study Group (SBCCSG)

Division name

Secretariat Division (Ninomiya hospital)

Zip code

330-0843

Address

491-6 shineicho, soka-shi, saitama-shi

TEL

048-941-2223

Homepage URL

http://www.sbccsg.org/

Email

jninomiya@grape.plala.or.jp


Sponsor or person

Institute

Sairtama Breast Cancer Clinical Study Group (SBCCSG)

Institute

Department

Personal name



Funding Source

Organization

Sairtama Breast Cancer Clinical Study Group (SBCCSG)

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Saitama Cancer Center

Address

780 komura ina kitaadachi Saitama Japan

Tel

0487221111

Email

sccctmo01@cancer-c.pref.saitama.jp


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

2016 Year 03 Month 23 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

2016 Year 02 Month 15 Day

Date of IRB


Anticipated trial start date

2016 Year 03 Month 24 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

2016 Year 03 Month 23 Day

Last modified on

2021 Year 03 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024896


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name