Unique ID issued by UMIN | UMIN000022256 |
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Receipt number | R000024427 |
Scientific Title | A multicenter, cooperative, randomized, comparative study regarding the efficacy of denosumab for bone loss related to postoperative endocrine therapy in postmenopausal patients with hormone-sensitive breast cancer |
Date of disclosure of the study information | 2016/07/01 |
Last modified on | 2023/05/16 22:33:02 |
A multicenter, cooperative, randomized, comparative study regarding the efficacy of denosumab for bone loss related to postoperative endocrine therapy in postmenopausal patients with hormone-sensitive breast cancer
The efficacy of the use of denosumab in the prevention of AI-induced bone loss in postmenopausal patients
A multicenter, cooperative, randomized, comparative study regarding the efficacy of denosumab for bone loss related to postoperative endocrine therapy in postmenopausal patients with hormone-sensitive breast cancer
The efficacy of the use of denosumab in the prevention of AI-induced bone loss in postmenopausal patients
Japan |
Breast Cancer
Breast surgery |
Malignancy
NO
To evaluate inhibitory effects of denosumab in the prevention of aromatase inhibitor-induced bone loss to postmenopausal patients with stage I-IIIA hormone-sensitive breast cancer who will intake an aromatase inhibitor as postoperative endocrine therapy.
Efficacy
Rate of change in the bone mineral density (BMD) for the lumbar vertebrae (L1-L4) on dual-energy X-ray absorptiometry (DXA) 12 months after the start of this study
1) Rate of change in the BMD for the lumbar vertebrae (L1-L4) on DXA: After 2, 3, 4, and 5 years
2) Rate of change in the BMD for the femoral neck: After 12 months and 2/3/4/5 years
3) Rate of change in the BMD for the radius (an ultrasonic bone densimeter is used): After 2 and 4 weeks, every 4 weeks thereafter (for 2 years after registration)(only institutions in which ultrasonic bone densimeters are used)
4) Changes in Ca and bone metabolism markers (TRAP5b, bone-specific alkaline phosphatase (BSAP), blood pentosidine)
5) Appearance of morbid fracture within 3 years
6) Disease-free survival
7) Overall survival
8) Appearance (type, incidence) of adverse events (such as hypocalcemia and necrosis of the jaw)
9) Quality of life (QOL), Japanese version Euro-Qol (EQ-5D-5L)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
2
Treatment
Medicine |
intake AI for 5 years and have subcutaneousinjection of denosumab every 6 months
only intake AI for 5 years
20 | years-old | <= |
Not applicable |
Female
1) Patients with infiltrative breast cancer, aged 20 and older years, meeting the following definitions:
-Those pathologically diagnosed with stage I, II, or IIIA breast cancer
-Those who underwent appropriate surgery, such as mastectomy and breast-preserving surgery
2) Estrogen receptor or progesterone receptor positive patients on immunohistochemical staining
3) Females meeting one of the following criteria for menopause:
-Those, aged 55 and older years, without menstruation
-Those, aged younger than 55 years, with amenorrhea for 12 and more months, or those diagnosed with menopause by attending physicians based on the FSH and estradiol levels
-Those who underwent bilateral oophorectomy
4) Patients in whom the BMD for the lumbar vertebrae (L1-L4) on DXA before the start of this study is -1.0SD and more of the mean value of young adult females (YAM), and the BMD for the femoral neck is -1.0SD and more of YAM
5) Patients without lumbar vertebral or femoral fracture
6) Those with an ECOG PS of 0-2
7) Those with adequate organ functions (laboratory data within 4 weeks before case registration)
-Leukocyte count, 3,000/mm3 and more or
Neutrophil count, 1,500/mm3 and more
-AST, ALT, 1.5 and less fold of the upper limit of the institutional reference range
-Serum creatinine, 1.5 and less fold of the upper limit of the institutional reference range
8) Case registration should be performed before the following point:
-Twelve weeks after the completion of surgery or postoperative chemotherapy
(The completion of chemotherapy refers to the completion of the final course, involving the recovery phase.)
9) Patients with an interval of 4 and less weeks after the discontinuation of therapy with bisphosphonates (oral preparations), estrogen preparations, raloxifene, calcitonin preparations, vitamin K preparations, active vitamin D preparations, or ipriflavone preparations, which influence bones
10) Those from whom written informed consent regarding study participation was obtained
1) Patients in whom distant metastasis was confirmed clinically or using imaging procedures at the time of case registration
2) Those with bilateral breast cancer
3) Those for whom postoperative hormonal therapy was started before consenting to study participation
4) Those who received endocrine therapy within 52 weeks before consenting to study participation
5) Those to whom bisphosphonate preparations were intravenously administered within 52 weeks before consenting to study participation
6) Those with the following diseases that may affect DXA
-Severe scoliosis, immobility, hyperostosis or osteosclerosis of the lumbar vertebrae, calcification of the abdominal aorta, and vertebral disease
7) Those with a history of malignant tumors other than breast cancer within 260 weeks before consenting to study participation
8) Those with dental diseases, such as infectious diseases of the teeth or jaw and tooth trauma. Those for whom tooth or jaw surgery is scheduled within 6 weeks after consenting to study participation (tooth extraction, implantation)
9) Others who are considered to be ineligible by the chief investigator
160
1st name | Koichi |
Middle name | |
Last name | Sakaguchi |
Kyoto Prefectural University of Medicine
Department of Endocrine and Breast Surgery
602-8566
465 kajii-cho Kawaramachi Hirokoji kamigyo-ku Kyoto Japan
075-251-5534
ksak@koto.kpu-m.ac.jp
1st name | Midori |
Middle name | |
Last name | Morita |
Kyoto Prefectural University of Medicine
Department of Endocrine and Breast Surgery
6028566
465 kajii-cho Kawaramachi Hirokoji kamigyo-ku Kyoto Japan
075-251-5534
midori@koto.kpu-m.ac.jp
Department of Endocrine and Breast Surgery, Kyoto Prefectural University of Medicine
Japanese Breast Cancer Society
Self funding
CTREC in Kyoto Prefectural University of Medicine
same as above
same as above
0752515111
rinri@koto.kpu-m.ac.jp
YES
NCT03324932
Clincal Trials.gov
京都府立医科大学
東京医科大学
浜松医科大学
呉医療センター
国立病院機構千葉医療センター
横浜市立大学附属市民総合医療センター
東海大学医学部付属病院
弘前大学
赤坂三浦クリニック
北海道がんセンター
神戸大学
東京慈恵会医科大学
獨協医科大学
総合上飯田第一病院
淀川キリスト教病院
明和病院
秋田大学
神戸海星病院
兵庫県立がんセンター
松下記念病院
市立奈良病院
済生会滋賀県病院
済生会京都府病院
大阪府済生会中津病院
加藤乳腺クリニック
亀岡市立病院
国際医療福祉大学成田病院
2016 | Year | 07 | Month | 01 | Day |
Unpublished
83
No longer recruiting
2016 | Year | 12 | Month | 20 | Day |
2016 | Year | 10 | Month | 04 | Day |
2017 | Year | 04 | Month | 20 | Day |
2022 | Year | 12 | Month | 31 | Day |
2023 | Year | 12 | Month | 31 | Day |
2027 | Year | 12 | Month | 31 | Day |
2027 | Year | 12 | Month | 31 | Day |
2016 | Year | 05 | Month | 10 | Day |
2023 | Year | 05 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024427
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