UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	Concurrent use of Sr-89 chloride with bone-modifying agent is safe and effective for breast cancer patients with painful bone metastases
Region	Japan

Condition
Condition	breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	incidence rates of myelotoxicity and hypocalcemia after fourth time uses of bone-modifying agent after use of Sr-89.
Key secondary outcomes	efficacy assessment to evaluated numerical rating scale, analgesic drug dosages, time to SRE, BAP or ALP, tumor marker, bone scintigraphy

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	concurrent use of the Sr-89 with bone-modifying agent (denosumab or zoredronic acid)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	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
Key exclusion criteria	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
Target sample size	15

Research contact person
Name of lead principal investigator	Koichiro Tsugawa
Organization	St. Marianna University School of Medicine
Division name	Breast and Endocrine Surgery
Address	2-16-1 Sugao, Miyamae, Kawasaki, Kanagawa, Japan
TEL	044-977-8111
Email	koitsuga@marianna-u.ac.jp

Public contact
Name of contact person	Tomoko Uejima
Organization	St. Marianna University School of Medicine
Division name	Breast and Endocrine Surgery
Address	2-16-1 Sugao, Miyamae, Kawasaki, Kanagawa, Japan
TEL	044-977-8111
Homepage URL
Email	chicoco@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	聖マリアンナ医科大学病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 19 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 05 Month 22 Day
Anticipated trial start date	2014 Year 06 Month 19 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 06 Month 15 Day
Last modified on	2017 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016583