Unique ID issued by UMIN | UMIN000010087 |
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Receipt number | R000010802 |
Scientific Title | Randomized Comparative Trial of High-dose FARESTON for Aromatase Inhibitor resistant breast cancer compared to Faslodex |
Date of disclosure of the study information | 2013/02/22 |
Last modified on | 2015/09/20 09:18:01 |
Randomized Comparative Trial of High-dose FARESTON for Aromatase Inhibitor resistant breast cancer compared to Faslodex
HI-FAIR fx Study
Randomized Comparative Trial of High-dose FARESTON for Aromatase Inhibitor resistant breast cancer compared to Faslodex
HI-FAIR fx Study
Japan |
Recurrent/advanced breast cancer patients with tumor which has relapsed after treatment of aromatase inhibitors
Hematology and clinical oncology | Breast surgery |
Malignancy
NO
Comparison of efficacy and safety between 120mg toremifene citrate and 500mg fulvestrant in the recurrent breast cancer patients with tumor which has relapsed after treatment of non-steriodal aromatase inhibitors
Safety,Efficacy
Confirmatory
Clinical Benefit Rate
response rate, time to progression, time to treatment failure, adverse events, presictive factor
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
TOR: Toremifene (120mg) is orally administered once a day everyday.
FUL: Fulvestrant (500mg) is intramuscular injected, day 1, day 15, day 28, followed by every 28 days.
30 | 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 30 year old)
4. The case who had progressive disease during or after the treatment of non-steroidal aromatase inhibitors
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
104
1st name | |
Middle name | |
Last name | Hirotaka Iwase |
Graduate School of Medical Sciences,
Kumamoto University
Department of Breast and Endocrine Surgery
1-1-1 Honjo, Chuo-ku Kumamoto
+81-96-373-5521
hiwase@kumamoto-u.ac.jp
1st name | |
Middle name | |
Last name | Yutaka Yamamoto |
Kumamoto University Hospital
Department of Breast Cancer Molecular Trageting Therapy
1-1-1 Honjo, Chuo-ku Kumamoto
+81-96-373-5521
http://www2.kuh.kumamoto-u.ac.jp/breast/index.html
ys-yama@triton.ocn.ne.jp
Department of Breast and Endocrine Surgery
Graduate School of Medical Sciences, Kumamoto University
Department of Breast and Endocrine Surgery
Graduate School of Medical Sciences, Kumamoto University
Self funding
YES
1517
Faculty of Life Sciences, Kumamoto University
熊本大学医学部附属病院(熊本県)、東京都立駒込病院(東京都)、横浜市立大学医療センター(神奈川県)、横浜労災病院(神奈川)、愛知県がんセンター中央病院(愛知県)、名古屋市立大学付属病院(愛知県)、福山市民病院(広島)
2013 | Year | 02 | Month | 22 | Day |
Unpublished
No longer recruiting
2012 | Year | 10 | Month | 26 | Day |
2012 | Year | 10 | Month | 29 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 05 | Month | 30 | Day |
2016 | Year | 07 | Month | 31 | Day |
2016 | Year | 08 | Month | 15 | Day |
2013 | Year | 02 | Month | 20 | Day |
2015 | Year | 09 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010802
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