Unique ID issued by UMIN | UMIN000015698 |
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Receipt number | R000018218 |
Scientific Title | Phase II trial of ethinylestradiol for aromatase inhibitor-resistant postmenopausal advanced/recurrent breast cancer patients |
Date of disclosure of the study information | 2014/11/17 |
Last modified on | 2018/11/18 10:01:40 |
Phase II trial of ethinylestradiol for aromatase inhibitor-resistant postmenopausal advanced/recurrent breast cancer patients
AIR-EE2
Phase II trial of ethinylestradiol for aromatase inhibitor-resistant postmenopausal advanced/recurrent breast cancer patients
AIR-EE2
Japan |
aromatase inhibitor-resistant advanced/recurrent breast cancer
Breast surgery |
Malignancy
NO
Evaluate the efficacy and safety of ethinylestradiol for aromatase inhibitor-resistant postmenopausal advanced/recurrent breast cancer patients.
Primary endpoint is the response rate.
Secondary endpoint is the clinical benefit rate, adverse drug reaction and progression-free survival.
Safety,Efficacy
Response Rate; RR
Clinical Benefit Rate; CBR
Adverse Drug Reaction; ADR
Progression-Free Survival; PFS
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Ethinylestradiol 3mg will be given orally everyday for 28 days.
Three cycle of ethinylestradiol will be given.
20 | years-old | <= |
80 | years-old | >= |
Female
1. Histologically confirmed breast cancer
2. Postmenopausal women with ER positive or PgR positive breast cancer
3. Measurable primary/metastatic lesion
4. Inoperable or metastatic breast cancer
5. Performance status 0, 1 or 2
6. Aromatase inhibitor-resistant
7. A case without severe complications and also meets the requirements below
1) WBC; more than 3,500/mm3, less than 10,000/mm3, Plt; more than 100,000/mm3, Hb; more than 10g/dl
2) T-Bil.; less than 1mg/dl, GOT; less than 60 IU/L, GPT; less than 60 IU/L
8. With written informed consent
1. Inflammatory breast cancer
2. Any malignant neoplasms
3. Severe cardiac disease(e.g. myocardial
infarction, valvular disease, heart failure)
4. Liver cirrhosis
5. Thrombosis
6. Judged inappropriate by physicians
40
1st name | |
Middle name | |
Last name | Hiromitsu Jinno |
Keio University School of Medicine
Department of Surgery
35 Shinanomachi Shinjuku, Tokyo, Japan
03-3353-1211
yokoe@z2.keio.jp
1st name | |
Middle name | |
Last name | Takamichi Yokoe |
Keio University School of Medicine
Department of Surgery
35 Shinanomachi Shinjuku, Tokyo, Japan
03-3353-1211
yokoe@z2.keio.jp
Keio University School of Medicine
Keio University School of Medicine
Self funding
NO
2014 | Year | 11 | Month | 17 | Day |
Unpublished
Terminated
2014 | Year | 11 | Month | 13 | Day |
2014 | Year | 12 | Month | 01 | Day |
2014 | Year | 11 | Month | 15 | Day |
2018 | Year | 11 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018218
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