UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II randomized clinical trial to investigate efficacy of zoledronic acid for the patients with metastatic or advanced breast cancer
Title of the study (Brief title)	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	Yasuaki Sagara
Organization	Sagara Hospital Hakuaikai Social Medical Corporation
Division name	Breast Surgery
Address	3-31, Matsubaracho, Kagoshima City, Kagoshima, 892-0833, Japan
TEL	0992241800
Email	yasuaki@sagara.or.jp

Public contact
Name of contact person	Syusyu Mitsuyama
Organization	Kyushu Breast Cancer Study Group (KBC-SG)
Division name	Oncology, hematology and infectious medicine, Fukuoka University Faculty of Medicine
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 05 Month 03 Day
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

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Publication of results	Unpublished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