Unique ID issued by UMIN | UMIN000030328 |
---|---|
Receipt number | R000021242 |
Scientific Title | The efficacy of re-challenge of denosumab in postmenopausal women with hormone receptor-positive breast cancer who are currently on or will iniate an aromatase inhibitor in the adjuvant setting |
Date of disclosure of the study information | 2017/12/09 |
Last modified on | 2018/06/10 09:43:44 |
The efficacy of re-challenge of denosumab in postmenopausal women with hormone receptor-positive breast cancer who are currently on or will iniate an aromatase inhibitor in the adjuvant setting
The efficacy of re-challenge of denosumab in postmenopausal women with hormone receptor-positive breast cancer
The efficacy of re-challenge of denosumab in postmenopausal women with hormone receptor-positive breast cancer who are currently on or will iniate an aromatase inhibitor in the adjuvant setting
The efficacy of re-challenge of denosumab in postmenopausal women with hormone receptor-positive breast cancer
Japan |
breast cancer
Breast surgery |
Malignancy
NO
To evaluate the re-challenge of denosumab in the prevention of aromatase inhibitor-induced bone loss in postmenopausal women with stage 1-3a hormone receptor-positive breast cancer who are currently on, or will iniate an aromataze inhibitor in the adujuvant setting
Efficacy
the percent change in lumbar spine(L1-L4)BMD from discontinuation to 12 month after
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
subcutaneous injection of denosumab every 6 months
20 | years-old | <= |
Not applicable |
Female
1) Adequately diagnosed and treated invasive breast cancer defined as 1.Clinical stage 1,2 or 3a 2.Patients with breast cancer whose tumor were removed by an appropriate surgical procedure such as mastectomy or breast conserving surgery
2) ER and PgR positive defined with immunohistochemical staining
3) Postmenopausal status defined by one of the following 1.women >54 years with cessation of menses 2.spontaneous cessation of menses within the past 1 years, but amenorrheic in women <55 years, and according to the definition of 'postmenopausal range' for FSH and estradiol level 3.bilateral oophorectomy
4) Lumbar spine, total hip or femoral neck BMD equivalent to a YAM classification of -1.0 to -2.5
5) ECOG Performance status of 0 to 2
6) Patients who have completed chemothrapy >4 weeks prior to study entry
7) Patients who have discontinued the following drugs known as affect to the skeleton more than 4 weeks oral bisphosphonates, estrogen, raloxifene, calcitonin, vitamin K, activated vitamin D, ipriflavone
8) A written informed consent is obtained
1) Diagnosis of clinical or radiological disant metastasis before inclusion
2) Invasive bilateral breast cancer
3) Received prior treatment with intravenous bisphosphonates within the past 12 months
4) Following diseases which may interfere with DXA scan such as severe scoliosis, vertebral diseases
5) Current active dental problems including infection of the teeth or jawbone. Recent (within 6 weeks) or planned dental or jaw surgery(e.g., extraction, implants)
6) Other conditions judged as inappropriate for the study by the investigator
10
1st name | |
Middle name | |
Last name | Tetsuya Taguchi |
Kyoto Prefectural University of medicine
Department of Endocrine and Breast Surgery
465 kajii-cho Kawaramachi Hirokoji kamigyo-ku Kyoto Japan
075-251-5534
ttagichi@koto.kpu-m.ac.jp
1st name | |
Middle name | |
Last name | yoshimi ouchi |
Kyoto Prefectural University of medicine
Department of Endocrine and Breast Surgery
465 kajii-cho Kawaramachi Hirokoji kamigyo-ku Kyoto Japan
075-251-5534
y-ouchi@koto.kpu-m.ac.jp
Kyoto Prefectural University of medicine
Kyoto Prefectural University of medicine
Department of Endocrine and Breast Surgery
Self funding
NO
2017 | Year | 12 | Month | 09 | Day |
Unpublished
No longer recruiting
2015 | Year | 07 | Month | 31 | Day |
2015 | Year | 10 | Month | 31 | Day |
2017 | Year | 12 | Month | 09 | Day |
2018 | Year | 06 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021242
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |