UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020690
Receipt number R000023867
Scientific Title Biomarker evaluation as the cardiotoxic evaluation index in the molecular target drug for breast cancer treatment
Date of disclosure of the study information 2016/01/21
Last modified on 2019/08/17 16:18:09

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Basic information

Public title

Biomarker evaluation as the cardiotoxic evaluation index in the molecular target drug for breast cancer treatment

Acronym

Biomarker evaluation as the cardiotoxic evaluation index in the molecular target drug for breast cancer treatment

Scientific Title

Biomarker evaluation as the cardiotoxic evaluation index in the molecular target drug for breast cancer treatment

Scientific Title:Acronym

Biomarker evaluation as the cardiotoxic evaluation index in the molecular target drug for breast cancer treatment

Region

Japan


Condition

Condition

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 whether you can predict cardiotoxic prognosis caused by the treatment with the molecular target drug of the breast cancer using biomarker(high-sensitivity troponin I;hsTnI, high-sensitivity troponin T;hs TnT, B-type natriuretic peptide;BNP)

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The cardiotoxicity that was defined according to a standard of CREC(the Cardiac Review and Evaluation Committee of Trastuzumab-associated cardiotoxicity)

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_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


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients with breast cancer that treatment with antiHER2 medicine is planned
2)By an explanation document, the agreements from a patient to a trial entry are provided

Key exclusion criteria

1)The patient who withdrew an agreement
2)Examination participation of the patients is taken as inappropriate by the medical attendant

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yoshinori
Middle name
Last name Ito

Organization

Cancer Institute Hospital of Japanese Foundation for Cancer Research

Division name

Breast Oncology

Zip code

135-8550

Address

3-8-31, Ariake, Koto-ku, Tokyo, Japan

TEL

03-3520-0111

Email

yito@jfcr.or.jp


Public contact

Name of contact person

1st name Yoshinori
Middle name
Last name Ito

Organization

Cancer Institute Hospital of Japanese Foundation for Cancer Research

Division name

Breast Oncology

Zip code

135-8550

Address

3-8-31, Ariake, Koto-ku, Tokyo, Japan

TEL

03-3520-0111

Homepage URL


Email

yito@jfcr.or.jp


Sponsor or person

Institute

Division of Breast Oncology,Cancer Institute Hospital of Japanese Foundation for Cancer Research

Institute

Department

Personal name



Funding Source

Organization

Abbott

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee of Cancer Institute Hospital of Japanese Foundation for Cancer Research

Address

3-8-31, Ariake, Koto-ku, Tokyo, Japan

Tel

03-3520-0111

Email

keiko.ohta@jfcr.or.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 01 Month 21 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

113

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

Completed

Date of protocol fixation

2014 Year 10 Month 14 Day

Date of IRB

2014 Year 10 Month 02 Day

Anticipated trial start date

2014 Year 11 Month 10 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study design : cohort study

Patients : From Nobember 10 2014 to Nobember 10 2016, all that meet the selection criteria in patients who were admitted to our hospital

endopoints:
Patient characteristics
therapy(operation,radiation,chemotherapy)
Perfrmance Status
clinical exams
biomarker, Echocardiography
1)HsTnI, hsTnT, BNP will be measured before chemotherapy and before anti-HER2 therapy, and on the prescribed date.
2)Echocardiography (LVEF, E/e', E/A, DcT) will be measured before chemotherapy and before anti-HER2 therapy, and on the prescribed date.


Management information

Registered date

2016 Year 01 Month 21 Day

Last modified on

2019 Year 08 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023867


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name