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Recruitment status Terminated
Unique ID issued by UMIN UMIN000027382
Receipt No. 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

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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
Email 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
Email npo@chotsg.com

Sponsor
Institute Kyushu Breast Cancer Study Group (KBC-SG)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031304

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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