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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001552
Receipt No. R000001875
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)
Date of disclosure of the study information 2008/12/05
Last modified on 2017/11/30

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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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