UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002831
Receipt number 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 16:04:09

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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