UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004365
Receipt No. R000005212
Scientific Title Effect of aromatase inhibitor with LH-RH agonisit for tamoxifen resistant recurrent breast cancer
Date of disclosure of the study information 2010/10/12
Last modified on 2010/10/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effect of aromatase inhibitor with LH-RH agonisit for tamoxifen resistant recurrent breast cancer
Acronym AI with LH-RH study
Scientific Title Effect of aromatase inhibitor with LH-RH agonisit for tamoxifen resistant recurrent breast cancer
Scientific Title:Acronym AI with LH-RH study
Region
Japan

Condition
Condition Recurrent breast cancer
Classification by specialty
Surgery in general Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Effect of aromatase inhibitor with LH-RH agonist for tamoxifen resistant recurrent breast cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Clinical Benefit
Key secondary outcomes time to progression and safety

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 recurrent after TAM traetment
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
80 years-old >
Gender Female
Key inclusion criteria ER positive recurrent breast cancer
Key exclusion criteria male breast cancer
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Tangoku
Organization Tokushima University Hospital
Division name Department of surgery
Zip code
Address 2-50 Kuramoto chou, Tokushima city
TEL 088-633-7141
Email

Public contact
Name of contact person
1st name
Middle name
Last name Michi Miki
Organization Institute of Health Bioscience
Division name Department of Thoracic endocrine surgery and Oncology
Zip code
Address 2-50Kuramoto
TEL 088-633-7143
Homepage URL http://www.tksbizan.com/
Email surgery2@clin.med.tokushima-u.ac.jp

Sponsor
Institute The University of Tokushima graduate school
Institute
Department

Funding Source
Organization The University of Tokushima graduate school
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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
2010 Year 10 Month 12 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 Preinitiation
Date of protocol fixation
2010 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
2014 Year 03 Month 01 Day
Date trial data considered complete
2014 Year 03 Month 01 Day
Date analysis concluded
2014 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 10 Month 10 Day
Last modified on
2010 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005212

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.