Unique ID issued by UMIN | UMIN000012225 |
---|---|
Receipt number | R000014256 |
Scientific Title | The efficacy and safety of Fluvestrant 500mg treatment in Japanese postmenopausal and hormone receptor positive and HER2 Negative metastatic Breast Cancer |
Date of disclosure of the study information | 2013/11/10 |
Last modified on | 2013/11/01 13:53:28 |
The efficacy and safety of Fluvestrant 500mg treatment in Japanese postmenopausal and hormone receptor positive and HER2 Negative metastatic Breast Cancer
AKBSG13-02
The efficacy and safety of Fluvestrant 500mg treatment in Japanese postmenopausal and hormone receptor positive and HER2 Negative metastatic Breast Cancer
AKBSG13-02
Japan |
ER positive postmenopausal advanced breast cancer
Breast surgery |
Malignancy
NO
Evaluate the contribution of Fulvestrant in patients with hormonal therapy pre threated to overall hormonal treatment sequence by confirming the efficacy of Fulveatrant and Nolvadex
Efficacy
Confirmatory
Pragmatic
Phase II
Clinical Benefit Rate of Fulvestrant CBR=Response Rate+LongSD(NC>=24week)
Changes in QOL
Chenges in BMD
chenges in fat metabolism
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Fulvesutrant,Tamoxifen
Not applicable |
Not applicable |
Female
1)Postmenopausal
2)Recurrence/Advance Breast Cancer
3)Histological confirmed invasive breast cancer by biopsy
4)Prior endocrine therapy
5)Measurable lesion
6)Cytological confirmed breast cancer
7)Estrogen receptor(ER)
positive by Immunohistochemistry(IHC=>1%)
confirmed by biopsy before treatment
8)Principal organs(bone marrow, heart, kidneys, etc.)are functionally preserved
9)ECOG performance status(P.S.)0,1or 2
10)Written informed consent
11)Patients projected to live at least for 3M or longer from the trial start
1)Active double cancer
2)Patients with active double cancer with less than 5years desease free intervals except for dissected carcinoma in situ or intramucosal cancer
3)noninfiltrating cancer
4)Inflammatory breast cancer
5)Serious complication
6)Heart disease that requires treatment, such as ischemic heart disease and abnormal cardiac rhythm (Left ventricular hypertrophy due to hypertension, non-severe left ventricle overload, or non-severe right bundle branch block can be included)
7)Brain metastasis
8)Medication of investigational new drug for diseases other than breast cancer or disorder Taking hormone replacement therapy or selective estrogen receptor
9)The case judged inappropriate by physicians
57
1st name | |
Middle name | |
Last name | Jun Horiguchi |
Gunma university school of medicine
Department of thoracic and visceral Organ surgery
3-39-22 Showa-machi, Maebashi City, Gunma Japan
027-2208245
junhorig@showa.gunma-u.ac.jp
1st name | |
Middle name | |
Last name | Toru Higuchi |
Gunma university school of medicine
Department of thoracic and visceral Organ surgery
3-39-22 Showa-machi, Maebashi City, Gunma Japan
027-2208245
m11702025@gunma-u.ac.jp
Gunma university
None
Self funding
NO
2013 | Year | 11 | Month | 10 | Day |
Unpublished
Preinitiation
2013 | Year | 10 | Month | 31 | Day |
2013 | Year | 11 | Month | 10 | Day |
2013 | Year | 11 | Month | 06 | Day |
2013 | Year | 11 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014256
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |