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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010797
Receipt No. R000012640
Scientific Title Exploratory study on predictive biomarkers for anti-HER2 drugs in breast cancer
Date of disclosure of the study information 2013/05/24
Last modified on 2019/09/24

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Basic information
Public title Exploratory study on predictive biomarkers for anti-HER2 drugs in breast cancer
Acronym Predictive markers for anti-HER2 drugs
Scientific Title Exploratory study on predictive biomarkers for anti-HER2 drugs in breast cancer
Scientific Title:Acronym Predictive markers for anti-HER2 drugs
Region
Japan

Condition
Condition HER2 positive breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To elucidate the mechanism of drug resistance to ant-HER2 drugs, leading to the improvement of clinical outcome for patients with HER2 positive breast cancer
Basic objectives2 Others
Basic objectives -Others To correlate the presence of somatic gene mutations in cancer cells and drug efficacy
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes To correlate the presence of somatic mutations in cancer cells and drug efficacy
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 Female
Key inclusion criteria 1.histologically diagnosed with invasive breast cancer,2.20 year or older, 3.IHC 3+ or HER2/CEP17>2.0 via FISH, 4. treated with lapatinib or trastuzumab, 5. archival tumor tissues available
Key exclusion criteria none
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki Saeki
Organization Saitama Medical University International Medical Center
Division name Surgery department
Zip code
Address 1397-1 Yamane, Hidaka, Saitama
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kinki University Faculty of Medicine
Division name Medical Oncology department
Zip code
Address
TEL 072-366-0221
Homepage URL
Email

Sponsor
Institute Ministry of Education, Culture Sports, Science and Technology
Institute
Department

Funding Source
Organization Ministry of Education, Culture Sports, Science and Technology
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 24 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 Open public recruiting
Date of protocol fixation
2012 Year 05 Month 30 Day
Date of IRB
2012 Year 10 Month 22 Day
Anticipated trial start date
2012 Year 05 Month 30 Day
Last follow-up date
2017 Year 05 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information preliminary results

Management information
Registered date
2013 Year 05 Month 24 Day
Last modified on
2019 Year 09 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012640

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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