UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004695 |
|---|---|
| Receipt number | R000005588 |
| Scientific Title | Health-Related Quality of Life of Premenopausal Women with Breast Cancer Treated with Adjuvant Endocrine Therapy Using Gosereline and Tamoxifen |
| Date of disclosure of the study information | 2010/12/09 |
| Last modified on | 2017/11/30 18:06:15 |
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Basic information
Public title
Health-Related Quality of Life of Premenopausal Women with Breast Cancer Treated with Adjuvant Endocrine Therapy Using Gosereline and Tamoxifen
Acronym
ZOLTAMQOL
Scientific Title
Health-Related Quality of Life of Premenopausal Women with Breast Cancer Treated with Adjuvant Endocrine Therapy Using Gosereline and Tamoxifen
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Takei |
Organization
Saitama Cancer Center
Division name
Division of Breast Surgery
Zip code
Address
818 komuro Ina, kita-Adachi, Saitama 362-0806
TEL
048-722-1111
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 (shin-toshin Ladies MammmoClinic)
Zip code
Address
3F,Capital Bldg 4-261-1 Kishiki Omiya, Saitama, Saitama 330-0843
TEL
048-600-1722
Homepage URL
toshikai@sbccsg.org
Sponsor or person
Institute
Saitama Breast Cancer Clinical Study Group (SBCCSG)
Institute
Department
Personal name
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
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 |
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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 10 | Month | 11 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005588
