Unique ID issued by UMIN | UMIN000002831 |
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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 |
Randomized Dose-Comparative Study of Estrogen Treatment in Postmenopausal Women with ER Positive Metastatic Breast Cancer after Failure of Sequential Endocrine Therapy
Estrogen Treatment in Postmenopausal Metastatic Breast Cancer after Failure of Sequential Endocrine Therapy
Randomized Dose-Comparative Study of Estrogen Treatment in Postmenopausal Women with ER Positive Metastatic Breast Cancer after Failure of Sequential Endocrine Therapy
Estrogen Treatment in Postmenopausal Metastatic Breast Cancer after Failure of Sequential Endocrine Therapy
Japan |
Metastatic breast cancer
Breast surgery |
Malignancy
NO
Randomized Dose-Comparative Study of Estrogen in Postmenopausal Women with ER Positive Metastatic Breast Cancer after Failure of Sequential Endocrine Therapy
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
clinical benefit rate
response rate, time to progression, time to treatment failure, adverse events, presictive factor
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Dose comparison
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
YES
Central registration
2
Treatment
Medicine |
ethinylestradiol 3mg
ethinylestradiol 6mg
50 | years-old | <= |
Not applicable |
Female
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
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
60
1st name | |
Middle name | |
Last name | Hirotaka Iwase |
Faculty of life sciences, Kumamoto University
Department of Breast and Endocrine Surgery
1-1-1 Honjo, Kumamoto
096-373-5521
hiwase@kumamoto-u.ac.jp
1st name | |
Middle name | |
Last name | Ayako Okabe |
Faculty of Medical and Pharmaceutical Sciences, Kumamoto University
Department of Breast and Endocrine Surgery
1-1-1 Honjo, Kumamoto
096-373-5521
http://www2.kuh.kumamoto-u.ac.jp/breast/index.html
breast@kumamoto-u.ac.jp
Department of Breast and Endocrine Surgery
Faculty of Medical and Pharmaceutical Sciences, Kumamoto University
Department of Breast and Endocrine Surgery
Faculty of Medical and Pharmaceutical Sciences, Kumamoto University
Self funding
NO
熊本大学医学部附属病院(熊本県)
2009 | Year | 12 | Month | 08 | Day |
http://www2.kuh.kumamoto-u.ac.jp/breast/index.html
Unpublished
In Jan 2011, 6 cases were registered with this trial.
Enrolling by invitation
2009 | Year | 11 | Month | 24 | Day |
2009 | Year | 11 | Month | 01 | Day |
2013 | Year | 11 | Month | 01 | Day |
2013 | Year | 11 | Month | 01 | Day |
2013 | Year | 11 | Month | 01 | Day |
2013 | Year | 11 | Month | 01 | Day |
2009 | Year | 12 | Month | 02 | Day |
2014 | Year | 02 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003456
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