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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037425
Receipt No. R000042420
Scientific Title Biomarker sub study of the phase II study of trastuzumab and pertuzumab combination therapy for HER2 amplified advanced solid tumors
Date of disclosure of the study information 2019/08/01
Last modified on 2020/07/08

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Basic information
Public title Biomarker sub study of the phase II study of trastuzumab and pertuzumab combination therapy for HER2 amplified advanced solid tumors
Acronym Biomarker study of HER2 basket study
Scientific Title Biomarker sub study of the phase II study of trastuzumab and pertuzumab combination therapy for HER2 amplified advanced solid tumors
Scientific Title:Acronym Biomarker study of HER2 basket study
Region
Japan

Condition
Condition HER2 amplified solid tumor
Classification by specialty
Hematology and clinical oncology Adult
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To explore genomic biomarkers for response of HER2 amplified advanced solid tumors to trastuzumab and pertuzumab combination therapy.
Basic objectives2 Others
Basic objectives -Others biomarker study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationships among genomic alterations and response
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 Participants of Phase II study
Written informed concent
Key exclusion criteria According to Phase II study.
Target sample size 38

Research contact person
Name of lead principal investigator
1st name Sadakatsu
Middle name
Last name Ikeda
Organization Tokyo Medical and Dental University
Division name Cancer center
Zip code 113-8510
Address 1-5-45, Yushima, Bunkyo
TEL 03-3813-6111
Email ext-her2-office@mpi-cro.jp

Public contact
Name of contact person
1st name Eri
Middle name
Last name Ishibashi
Organization Tokyo Medical and Dental University
Division name Medical Innovation center
Zip code 1138510
Address 1-5-45, Yushima, Bunkyo
TEL 03-3813-6111
Homepage URL
Email ext-her2-office@mpi-cro.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Medical and Dental university IRB
Address 1-5-45, yushima, bunkyo
Tel 03-3813-6111
Email tiken.crc@tmd.ac.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
2019 Year 08 Month 01 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
2019 Year 07 Month 01 Day
Date of IRB
2019 Year 09 Month 25 Day
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Data will be collected for the study as follows.
-cancer-related mutations (pre- and post-treatment)
-tumor response

Management information
Registered date
2019 Year 07 Month 19 Day
Last modified on
2020 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042420

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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