UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000967 |
|---|---|
| Receipt number | 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 18:06:28 |
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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
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/
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001165
