UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018294
Receipt number R000020788
Scientific Title Feasibility study of a short Trastuzumab infusion in patients with breast cancer.
Date of disclosure of the study information 2015/07/21
Last modified on 2019/04/24 13:27:03

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Basic information

Public title

Feasibility study of a short Trastuzumab infusion in patients with breast cancer.

Acronym

Feasibility study of a short Trastuzumab infusion in patients with breast cancer.

Scientific Title

Feasibility study of a short Trastuzumab infusion in patients with breast cancer.

Scientific Title:Acronym

Feasibility study of a short Trastuzumab infusion in patients with breast cancer.

Region

Japan


Condition

Condition

breast cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety profile of a short infusion of Trastuzumab in Japanese breast cancer patients.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Having onset of hypersensitivity reaction or not

Key secondary outcomes

grade of infusion related
reaction(CTCAE v.4.0),feasibility,causality of between hypersensitivity and BMI and stage


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 Maneuver

Interventions/Control_1

Trastuzumab is administered in 0.2mg/kg/min.

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

Female

Key inclusion criteria

1)HER2 positive(either 3+ overexpression by IHC or positive by FISH) breast cancer of stage 1-3
2)outpatients
3)Age 20 years and above
4)ECOG PS 0-3
5)No prior therapy of trastuzumab
6)Written informed consent

Key exclusion criteria

1)Systemic administration of corticosteroids
2)At the same time, used other molecular target drugs
3)Patients whose participation in the trial is judged to be inappropriate by the attending doctor

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akiko Konomatsu

Organization

NIPPON MEDICAL SCHOOL MUSASHI KOSUGI HOSPITAL

Division name

Pharmacy

Zip code


Address

1-396,KOSUGI-CHO NAKAHARAKU,KAWASAKI KANAGAWA

TEL

044-733-5181

Email

akk-koo@nms.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akiko Konomatsu

Organization

NIPPON MEDICAL SCHOOL MUSASHI KOSUGI HOSPITAL

Division name

Pharmacy

Zip code


Address

1-396,KOSUGI-CHO NAKAHARAKU,KAWASAKI KANAGAWA

TEL

044-733-5181

Homepage URL


Email

akk-koo@nms.ac.jp


Sponsor or person

Institute

NIPPON MEDICAL SCHOOL MUSASHI KOSUGI HOSPITAL

Institute

Department

Personal name



Funding Source

Organization

none

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


Address


Tel


Email



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

日本医科大学武蔵杉病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2015 Year 07 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


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

2015 Year 05 Month 07 Day

Date of IRB

2015 Year 05 Month 07 Day

Anticipated trial start date

2015 Year 06 Month 01 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



Management information

Registered date

2015 Year 07 Month 13 Day

Last modified on

2019 Year 04 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020788


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name