Unique ID issued by UMIN | UMIN000014269 |
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Receipt number | R000016583 |
Scientific Title | Concurrent use of Sr-89 chloride with bone-modifying agent(denosumab, zoledronic acid) is safe and effective for breast cancer patients with painful bone metastases |
Date of disclosure of the study information | 2014/06/19 |
Last modified on | 2017/12/19 11:27:52 |
Concurrent use of Sr-89 chloride with bone-modifying agent(denosumab, zoledronic acid) is safe and effective for breast cancer patients with painful bone metastases
Concurrent use of Sr-89 chloride with bone-modifying agent is safe and effective for breast cancer patients with painful bone metastases
Concurrent use of Sr-89 chloride with bone-modifying agent(denosumab, zoledronic acid) is safe and effective for breast cancer patients with painful bone metastases
Concurrent use of Sr-89 chloride with bone-modifying agent is safe and effective for breast cancer patients with painful bone metastases
Japan |
breast cancer
Breast surgery |
Malignancy
NO
to examine the safety and efficacy of the concurrent use of the radiopharmaceutical strontium-89 (Sr-89) chloride with bone-modifying agent (denosumab, zoledronic acid) for breast cancer patients with painful bone metastases.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
incidence rates of myelotoxicity and hypocalcemia after fourth time uses of bone-modifying agent after use of Sr-89.
efficacy assessment to evaluated numerical rating scale, analgesic drug dosages, time to SRE, BAP or ALP, tumor marker, bone scintigraphy
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
concurrent use of the Sr-89 with bone-modifying agent (denosumab or zoredronic acid)
18 | years-old | <= |
Not applicable |
Female
1.breast cancer diagnosed with histologic or cytologic examination.
2.painful bone metastases indicated by bone scintigraphy .
3.primary medication used for Sr-89.
4.painful or not controlled pain with analgesic.
5. WBC>3000/mm3, neutrophilic leukocyte >1500/mm3, plt>75000/3, Hb>9.0g/dl
6. serum Cr<1.2mg/dl or creatinine clearance>60ml/min
7. Performance Status 0-2
1. a case indicated chemotherapy
2. a case that has other cancer
3. a case that has grave complication
4. a case that has grave bone marrow suppression
5. a case that has grave renal dysfunction
6. a case that has invasive dental treatment
7. a woman that is pregnant, breast-feed and may be pregnant
15
1st name | |
Middle name | |
Last name | Koichiro Tsugawa |
St. Marianna University School of Medicine
Breast and Endocrine Surgery
2-16-1 Sugao, Miyamae, Kawasaki, Kanagawa, Japan
044-977-8111
koitsuga@marianna-u.ac.jp
1st name | |
Middle name | |
Last name | Tomoko Uejima |
St. Marianna University School of Medicine
Breast and Endocrine Surgery
2-16-1 Sugao, Miyamae, Kawasaki, Kanagawa, Japan
044-977-8111
chicoco@marianna-u.ac.jp
St. Marianna University School of Medicine
none
Self funding
NO
聖マリアンナ医科大学病院(神奈川県)
2014 | Year | 06 | Month | 19 | Day |
Unpublished
Terminated
2014 | Year | 05 | Month | 22 | Day |
2014 | Year | 06 | Month | 19 | Day |
2017 | Year | 03 | Month | 31 | Day |
2014 | Year | 06 | Month | 15 | Day |
2017 | Year | 12 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016583
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