UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027382 |
|---|---|
| Receipt number | R000031304 |
| Scientific Title | Phase II randomized clinical trial to investigate efficacy of zoledronic acid for the patients with metastatic or advanced breast cancer |
| Date of disclosure of the study information | 2017/05/19 |
| Last modified on | 2017/05/18 11:50:31 |
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Basic information
Public title
Phase II randomized clinical trial to investigate efficacy of zoledronic acid for the patients with metastatic or advanced breast cancer
Acronym
Randomized clinical trial to investigate efficacy of zoledronic acid for the patients with metastatic or advanced breast cancer
Scientific Title
Phase II randomized clinical trial to investigate efficacy of zoledronic acid for the patients with metastatic or advanced breast cancer
Scientific Title:Acronym
Randomized clinical trial to investigate efficacy of zoledronic acid for the patients with metastatic or advanced breast cancer
Region
| Japan |
Condition
Condition
Metastatic breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate anti-tumor effect and safety of zoledronic acid for the patients with metastatic and recurrent breast cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival, PFS
Key secondary outcomes
Response rate, RR
clinical benefit rate (after 24 weeks)
Skeletal related events, SRE
Time to bone metastasis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Zoledronic acid + standard chemotherapy
Interventions/Control_2
Standard chemotherapy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) histologically or cytologically proven breast cancer
2) HER-2 negative breast cancer
3) Stage IV or recurrent breast cancer
4) No evidence of bone metastasis
5) There is a lesion to be evaluated by RECIST
Key exclusion criteria
1) There is any infection or complication of teeth
2) History of allergy by zoledronic acud
3) Patients with osteoporosis who needs therapy by bisphosphonates
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuaki Sagara |
Organization
Sagara Hospital Hakuaikai Social Medical Corporation
Division name
Breast Surgery
Zip code
Address
3-31, Matsubaracho, Kagoshima City, Kagoshima, 892-0833, Japan
TEL
0992241800
yasuaki@sagara.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Syusyu Mitsuyama |
Organization
Kyushu Breast Cancer Study Group (KBC-SG)
Division name
Oncology, hematology and infectious medicine, Fukuoka University Faculty of Medicine
Zip code
Address
7-45-1, Nanakuma, Jyonan, Fukuoka City, Fukuoka, 812-0180, Japan
TEL
0928012845
Homepage URL
npo@chotsg.com
Sponsor or person
Institute
Kyushu Breast Cancer Study Group (KBC-SG)
Institute
Department
Personal name
Funding Source
Organization
Clinical Hematology Oncology Treatment Study Group
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2009 | Year | 05 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 18 | Day |
Last modified on
| 2017 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031304
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
