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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000000967
Receipt No. R000001165
Scientific Title Assessment of the Efficacy of High-Dose Toremifene 120mg Therapy for Anastorozole-resistant Postmenopausal Breast Cancer (SBCCSG-11)
Date of disclosure of the study information 2008/01/07
Last modified on 2017/11/30

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Basic information
Public title Assessment of the Efficacy of High-Dose Toremifene 120mg Therapy for Anastorozole-resistant Postmenopausal Breast Cancer (SBCCSG-11)
Acronym Assessment of the Efficacy of High-Dose Toremifene 120mg Therapy for Anastorozole-resistant Postmenopausal Breast Cancer (SBCCSG-11)
Scientific Title Assessment of the Efficacy of High-Dose Toremifene 120mg Therapy for Anastorozole-resistant Postmenopausal Breast Cancer (SBCCSG-11)
Scientific Title:Acronym Assessment of the Efficacy of High-Dose Toremifene 120mg Therapy for Anastorozole-resistant Postmenopausal Breast Cancer (SBCCSG-11)
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 Postmenopausal breast cancer patients who were relapsed during or within one year after completion of anastorozole treatment received high-dose toremifene,and efficacy and predictive factors were assessed.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes clinical benefit
Key secondary outcomes 1. clinical responce rate
2. progression free survival(PFS)
3. time to progression(TTP)
4. adverse events

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 Toremifene (120mg) is orally administered once a day everyday.
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
50 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1. A written consent is obtained
2. Patients diagnosed histologically as having had breast cancer at primary lesion
3. Patients relapsed during or after winthin one year completion of anastrozole treatment
4. PS(ECOG):0-2
5. Patients having measurable lesion or assessable bone lesion
6.
7. Patients with expected lifetime for more than 3 months
8. Patients with bone metastasis without radiotherapy

Key exclusion criteria 1. Patients under anti-estrogen hormone therapy
2. Patients under hormone therapy except for anastrozole
3. Patients diagnosed as inflammatory breast cancer
4. Patients with a history of deep venous thrombosis
5. Patients with serious complications
A. Patients with ischemic heart disease or cardiac arrhythmia that need treatment(left ventricular hypertrophy or mild left ventricular load induced by hypertension,or mild right bundle-branch block is eligible)
B. Patients with a history of myocardial infarction within 6 months onset
C. Patietns with uncontrollable diabetes
6. Patients with brain metastasis
7. Patients taking raloxifen (belonging to SERM) for treatment of osteoporosis
8. Doctor's decision for exclusion
Target sample size 40

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 Kitaadati, Saitama 362-0806
TEL 048-722-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiro Kai
Organization Shintoshin Ladies' Mammoclinic
Division name Saitama Breast Cancer Clinical Study Group Executive office
Zip code
Address 3F,Capital Bldg. 4-261-1,Kishiki-cho,Omiya-ku,Saitama-city ,Saitama 330-0843
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)

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 01 Month 07 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 Terminated
Date of protocol fixation
2007 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2008 Year 01 Month 01 Day
Last follow-up date
2013 Year 01 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 01 Month 06 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=R000001165

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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