UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034475
Receipt number R000010528
Scientific Title Assessment of safety on trastuzumab with varied dilution solution volume in HER2 positive breast cancer
Date of disclosure of the study information 2018/10/12
Last modified on 2018/10/12 22:31:38

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Basic information

Public title

Assessment of safety on trastuzumab with varied dilution solution volume in HER2 positive breast cancer

Acronym

Assessment of safety on trastuzumab with varied dilution solution volume in HER2 positive breast cancer

Scientific Title

Assessment of safety on trastuzumab with varied dilution solution volume in HER2 positive breast cancer

Scientific Title:Acronym

Assessment of safety on trastuzumab with varied dilution solution volume in HER2 positive breast cancer

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the safety on intravenously administered trastuzumab with vaired dilution solution volume and to determine the optimal concentration level

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

To evaluate MTD and RD

Key secondary outcomes

serious incidence of infusion reaction after the first treatment with trastuzumab


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

level 1
After the first trastuzumab treatment: 2mg/kg of trastuzumab with 100 ml saline solution administered intravenously over 30 minutes
level 2
After the first trastuzumab treatment: 6mg/kg of trastuzumab with 100 ml saline solution administered intravenously over 30 minutes
level 3
After the first trastuzumab treatment: 8mg/kg of trastuzumab with 100 ml saline solution administered intravenously over 30 minutes

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) 20 years of age or more
2) HER2 overexpression confirmed by IHC or FISH
3) recieving neo-adjuvant or adjuvant therapy with trastuzumab
4) recieving mono trastuzumab treatment
5) Baseline left ventricular ejection fraction; above 50% based on echocardiography or MUGA scan in last 3months
6)Signed informed consent

Key exclusion criteria

1) with severe allergy to trastuzumab
2) Judjed ineligible based on physicians' decision

Target sample size

9


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahiko Watanabe

Organization

Kitasato University School of Medicine

Division name

Department of Surgery

Zip code


Address

1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375.

TEL

0427788111

Email

y-kosaka@med.kitasato-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Norihiko Sengoku

Organization

Kitasato University School of Medicine

Division name

Department of Surgery

Zip code


Address

1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375.

TEL

0427788111

Homepage URL


Email

y-kosaka@med.kitasato-u.ac.jp


Sponsor or person

Institute

Kitasato University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kitasato University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

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

北里大学医学部(神奈川県)


Other administrative information

Date of disclosure of the study information

2018 Year 10 Month 12 Day


Related information

URL releasing protocol


Publication of results

Published


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

2012 Year 06 Month 15 Day

Date of IRB


Anticipated trial start date

2012 Year 09 Month 15 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

2018 Year 10 Month 12 Day

Last modified on

2018 Year 10 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010528


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name