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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002831
Receipt No. R000003456
Scientific Title Randomized Dose-Comparative Study of Estrogen Treatment in Postmenopausal Women with ER Positive Metastatic Breast Cancer after Failure of Sequential Endocrine Therapy
Date of disclosure of the study information 2009/12/08
Last modified on 2014/02/20

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Basic information
Public title Randomized Dose-Comparative Study of Estrogen Treatment in Postmenopausal Women with ER Positive Metastatic Breast Cancer after Failure of Sequential Endocrine Therapy
Acronym Estrogen Treatment in Postmenopausal Metastatic Breast Cancer after Failure of Sequential Endocrine Therapy
Scientific Title Randomized Dose-Comparative Study of Estrogen Treatment in Postmenopausal Women with ER Positive Metastatic Breast Cancer after Failure of Sequential Endocrine Therapy
Scientific Title:Acronym Estrogen Treatment in Postmenopausal Metastatic Breast Cancer after Failure of Sequential Endocrine Therapy
Region
Japan

Condition
Condition Metastatic breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Randomized Dose-Comparative Study of Estrogen in Postmenopausal Women with ER Positive Metastatic Breast Cancer after Failure of Sequential Endocrine Therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes clinical benefit rate
Key secondary outcomes response rate, time to progression, time to treatment failure, adverse events, presictive factor

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 ethinylestradiol 3mg
Interventions/Control_2 ethinylestradiol 6mg
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
50 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1. The case signed informed consent of the patients for the registration
2. The case confirmed by pathological diagnosis
3. postmenopausal women with breast cancer (not less than 50 year old)
4. The case who had progressive disease during the sequential treatments of aromatase inhibitors or SERMs
5. The case with measurable metastatic / recurrent site or evaluable bone metastasis
6. The case with ER positive and/or PgR positive
7. The case that survival more than six months is anticipated
8. The case with PS 0 or 1, additionally the case with PS 2 only by bone metastasis
9. The case with a satisfactory function of a heart/liver/kidney/bone marrow and to satisfy the next condition
Hb: more than 8g/dl
AST(GOT), ALT(GPT): Less than 2.5 times of the normal value upper limit of the institution
Key exclusion criteria 1. The case with active other malignancies
2. The case with past history of drug allergy or hypersensitivity
3. The case during pregnancy or lactation
4. The case with severe progressive situation with non-indication for the hormone therapy
5. The case judged inappropriate by physicians
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotaka Iwase
Organization Faculty of life sciences, Kumamoto University
Division name Department of Breast and Endocrine Surgery
Zip code
Address 1-1-1 Honjo, Kumamoto
TEL 096-373-5521
Email hiwase@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ayako Okabe
Organization Faculty of Medical and Pharmaceutical Sciences, Kumamoto University
Division name Department of Breast and Endocrine Surgery
Zip code
Address 1-1-1 Honjo, Kumamoto
TEL 096-373-5521
Homepage URL http://www2.kuh.kumamoto-u.ac.jp/breast/index.html
Email breast@kumamoto-u.ac.jp

Sponsor
Institute Department of Breast and Endocrine Surgery
Faculty of Medical and Pharmaceutical Sciences, Kumamoto University
Institute
Department

Funding Source
Organization Department of Breast and Endocrine Surgery
Faculty of Medical and Pharmaceutical Sciences, Kumamoto University
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 熊本大学医学部附属病院(熊本県)

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 08 Day

Related information
URL releasing protocol http://www2.kuh.kumamoto-u.ac.jp/breast/index.html
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
In Jan 2011, 6 cases were registered with this trial.
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 Enrolling by invitation
Date of protocol fixation
2009 Year 11 Month 24 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2013 Year 11 Month 01 Day
Date of closure to data entry
2013 Year 11 Month 01 Day
Date trial data considered complete
2013 Year 11 Month 01 Day
Date analysis concluded
2013 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 12 Month 02 Day
Last modified on
2014 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003456

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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