UMIN-CTR Clinical Trial

Basic information
Public title	Health-related quality of life of postmenopausal women treated with Letrozole as adjuvant therapy for hormone receptor-positive early breast cancer (SBCCSG-15)
Acronym	Health-related quality of life of postmenopausal women treated with Letrozole as adjuvant therapy for hormone receptor-positive early breast cancer (SBCCSG-15)
Scientific Title	Health-related quality of life of postmenopausal women treated with Letrozole as adjuvant therapy for hormone receptor-positive early breast cancer (SBCCSG-15)
Scientific Title:Acronym	Health-related quality of life of postmenopausal women treated with Letrozole as adjuvant therapy for hormone receptor-positive early breast cancer (SBCCSG-15)
Region	Japan

Condition
Condition	postmenopausal breast cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluate health related quality of life during treated with Letrozole as adjuvant therapy for hormone receptor-positive early breast cancer and analyze by the difference of baseline characteristics ( e.g age, comorbidity, treatment ). Assess arthralgia, one of the most common adverse events, in detail.
Basic objectives2	Others
Basic objectives -Others	HRQOL
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change rate of FACT-ES score
Key secondary outcomes	Change rate of FACT-G score Arthralgia related with AI FACT-ES score by baseline characters before and after treatment Difference of the evaluation of arthralgia between investigators and patients-self

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Letrozole 2.5mg daily p.o. as adjuvant therapy
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. histologically diagnosed with unilateral primary breast cancer, stage 0-IIIC. ( previous local radiotherapy and/or systemic chemotherapy are allowed ) 2. ER and/or PgR positive 3. PS(ECOG)0,1 4. postmenopausal patients who satisfies one or more below criteria; A. age 60 or more B. Prior bilateral oophorectomy C. amenorrheic for 1 year or more D. FSH and plasma estradiol level in postmenopausal ranges 5. adequate major organ function 6. informed consent has been obtained in writing
Key exclusion criteria	1. patients have been treated with medicine which may have some effect for sex hormone or trastuzumab 2. patients being treated with chemotherapy 3. Serious complications ( e.g malignant hypertension, CHF, hepatic failure, MI within 6 months, PE, arrhythmia treatment needed, infection, hemorrhagic tendency ) 4. active multiple cancer
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Toshio Tabei
Organization	Saitama Cancer Center
Division name	Breast Oncology
Zip code
Address	818 Komuro Ina Kitaadachi, Saitama 362-0806
TEL	048-722-1111
Email	toshikai@sbccsg.org

Public contact
Name of contact person	1st name Middle name Last name Toshihiro Kai
Organization	NPO Saitama Breast Cancer Clinical Study Group (SBCCSG)
Division name	Executive office(c/o: Shin-toshin Ladies MammoClinic)
Zip code
Address	3F, Capital Bldg. 4-261-1, Kishiki-cho, Omiya-ku, Saitama-City 330-0843, Saitama Prefecture
TEL	048-600-1722
Homepage URL	http://www.sbccsg.org/
Email	toshikai@sbccsg.org

Sponsor
Institute	NPO 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)

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	2008 Year 12 Month 05 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	No longer recruiting
Date of protocol fixation	2008 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date	2008 Year 12 Month 01 Day
Last follow-up date	2011 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2008 Year 12 Month 04 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=R000001875

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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