UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Health-Related Quality of Life of Premenopausal Women with Breast Cancer Treated with Adjuvant Endocrine Therapy Using Gosereline and Tamoxifen
Title of the study (Brief title)	ZOLTAMQOL
Region	Japan

Condition
Condition	Premenopausal Breast Cancer
Classification by specialty	Endocrinology and Metabolism Hematology and clinical oncology Surgery in general Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Primary end point is to evaluate health related quality of life by measuring changes of FACT-ES and FACT-B scores in premenopausal women with breast cancer treated with gosereline and tamoxifen.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in FACT-ES and FACT-B scores
Key secondary outcomes	Bone mineral density, Disease-free survival, Adverse events, Calcium intake by questionnaires

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.Premenopausal women with invasive breast cancer who underwent surgery Definition of premenopause 1-1.Menstruation within one year 1-2.Estradiol and FSH levels are within premenopausal limits 2.Stage I-IIIB (T1-4, N0-2, M0) 3.Estrogen receptor positive 4.Treated with no chemothreapy 5.Planed to be treated with gosereline and tamoxifen 6.Having adequate organ functions 7.PS 0,1 (ECOG) 8.Written informed consent
Key exclusion criteria	1.Suffering other active cancers 2.Having simultaneously diagnosed other cancers or having another invasive cancer diagnosed within past 5 years 3.Ductal carcinoma in situ 4.Inflammatory breast cancer 5.Being pregnant 6.Being treated with LHRH analogue for other diseases 7.having severe menopausal symptoms 8.Being inappropriate by an investigators' decision
Target sample size	50

Research contact person
Name of lead principal investigator	Hiroyuki Takei
Organization	Saitama Cancer Center
Division name	Division of Breast Surgery
Address	818 komuro Ina, kita-Adachi, Saitama 362-0806
TEL	048-722-1111
Email	toshikai@sbccsg.org

Public contact
Name of contact person	Toshihiro Kai
Organization	NPO Saitama Breast Cancer Clinical Study Group (SBCCSG)
Division name	Executive office (shin-toshin Ladies MammmoClinic)
Address	3F,Capital Bldg 4-261-1 Kishiki Omiya, Saitama, Saitama 330-0843
TEL	048-600-1722
Homepage URL
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	さいたま赤十字病院（埼玉県）、埼玉県立がんセンター（埼玉県）、川口市立医療センター（埼玉県）、自治医科大学付属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）、深谷赤十字病院（埼玉県）、春日部市立病院（埼玉県）、三井病院（埼玉県）、獨協医科大学越谷病院（埼玉県）、埼玉医科大学国際医療センター（埼玉県）、埼玉医科大学総合医療センター（埼玉県）、防衛医科大学（埼玉県）、戸田中央病院（埼玉県）、済生会栗橋病院（埼玉県）、こう外科クリニック（埼玉県）、二宮病院（埼玉県）、伊奈病院（埼玉県）、新都心レディースクリニック（埼玉県）

Other administrative information
Date of disclosure of the study information	2010 Year 12 Month 09 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2010 Year 10 Month 11 Day
Anticipated trial start date	2010 Year 12 Month 01 Day
Last follow-up date	2014 Year 12 Month 01 Day
Date of closure to data entry	2015 Year 01 Month 01 Day
Date trial data considered complete	2015 Year 03 Month 01 Day
Date analysis concluded	2015 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Primary end point is to evaluate health related quality of life by measuring changes of FACT-ES and FACT-B scores in premenopausal women with breast cancer treated with gosereline and tamoxifen.

Management information
Registered date	2010 Year 12 Month 09 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=R000005588