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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032570
Receipt No. R000037143
Scientific Title Evaluation of everolimus pneumonitis and clinical efficacy: a multi-institutional retrospective study
Date of disclosure of the study information 2018/05/14
Last modified on 2018/05/13

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Basic information
Public title Evaluation of everolimus pneumonitis and clinical efficacy: a multi-institutional retrospective study
Acronym Evaluation of everolimus pneumonitis and clinical efficacy
Scientific Title Evaluation of everolimus pneumonitis and clinical efficacy: a multi-institutional retrospective study
Scientific Title:Acronym Evaluation of everolimus pneumonitis and clinical efficacy
Region
Japan

Condition
Condition HER2-negative advanced/metastatic breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of everolimus pneumonitis and clinical efficacy in clinical setting
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes frequency of everolimus pneumonitis
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. ER positive and/or PgR positive
2. HER2 negative
3. patient with administration of everolimus for more than 1 week
Key exclusion criteria nothing
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichiro Kikawa
Organization Kobe city medical center general hospital
Division name Breast surgery
Zip code
Address 2-2-1, Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo
TEL 078-302-4321
Email u-1ro@kcho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Kotake
Organization Kyoto University Hospital
Division name Breast surgery
Zip code
Address 54, Kawaharacho Shogoin Sakyoku, Kyoto
TEL 0757513660
Homepage URL
Email tkkotake@gmail.com

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization No
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

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 14 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
2017 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information retrospective study

Management information
Registered date
2018 Year 05 Month 13 Day
Last modified on
2018 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037143

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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