UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A observational study for safety and efficacy of Fulvestrant 500mg in postmenopausal patients with ER positive advanced or recurrent breast cancer after prior endocrine treatment. (SBCCSG-29)
Title of the study (Brief title)	SBCCSG-29:Fulvestrant observational study
Region	Japan

Condition
Condition	Locally advanced or metastatic breast cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To collect and evaluate real-life data of patients with ER+ advanced breast cancer treated with Fulvestrant 500mg regimen.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Time to treatment failure(TTF)
Key secondary outcomes	Overall survival(OS), Clinical benefit rate(CBR), Response rate(RR), Safety

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1.Postmenopausal breast cancer. 2.Histological confirmation of breast cancer. 3.Histologically proven invasive breast cancer. 4.Patients who is receiving or planning to receive Fulvestrant therapy. 5.Prior endocrine therapy for breast cancer besides Fulvestrant therapy. 6.Estrogen receptor positive (>1% by IHC). 7.Adequate marrow, cardiac, kidney and liver function. 8.In principle signed written informed consent was obtained from patients.
Key exclusion criteria	1.Current or prior double cancer within 5 years. 2.Non-invasive breast cancer. 3.Inflammatory breast cancer. 4.An existing serious, uncontrolled cardiac disease. 5.Brain metastasis.
Target sample size	100

Research contact person
Name of lead principal investigator	Kei Kimuzuka
Organization	Kasukabe Municipal Hospital
Division name	Surgery
Address	7-2-1, chuo, Kasukabe-si, Saitama prefecture
TEL	048-735-1261
Email	keisurg@cd5.so-net.ne.jp

Public contact
Name of contact person	Toshihiro Kai
Organization	Saitama Breast Cancer Clinical Study Group(SBCCSG)
Division name	Secretariat Division (Shintoshin Ladies' Mammo Clinic)
Address	3F Capital building, 4-261-1 Kishiki-cho, Omiya-ku, Saitama-shi, 330-0843, Japan
TEL	048-600-1722
Homepage URL	http://www.sbccsg.org/
Email	toshikai@sbccsg.org

Sponsor
Institute	Saitama Breast Cancer Clinical Study Group(SBCCSG)
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	春日部市立病院（埼玉県），埼玉県立がんセンター（埼玉県），さいたま赤十字病院（埼玉県），自治医大さいたま医療センター（埼玉県），赤心堂病院（埼玉県），埼玉社会保険病院（埼玉県）

Other administrative information
Date of disclosure of the study information	2012 Year 10 Month 15 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2012 Year 09 Month 12 Day
Anticipated trial start date	2012 Year 10 Month 15 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	To collect and evaluate real-life data of patients with ER+ advanced breast cancer treated with Fulvestrant 500mg regimen.

Management information
Registered date	2012 Year 10 Month 14 Day
Last modified on	2017 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010683