UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000489 |
|---|---|
| Receipt number | R000000594 |
| Scientific Title | Study of High dose Toremifene for metastatic breast cancer after failure of adjuvant therapy of Aromatase Inhibitor |
| Date of disclosure of the study information | 2006/10/01 |
| Last modified on | 2014/05/07 09:32:07 |
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Basic information
Public title
Study of High dose Toremifene for metastatic breast cancer after failure of adjuvant therapy of Aromatase Inhibitor
Acronym
Study of High dose Toremifene for metastatic breast cancer after failure of adjuvant therapy of Aromatase Inhibitor
Scientific Title
Study of High dose Toremifene for metastatic breast cancer after failure of adjuvant therapy of Aromatase Inhibitor
Scientific Title:Acronym
Study of High dose Toremifene for metastatic breast cancer after failure of adjuvant therapy of Aromatase Inhibitor
Region
| Japan |
Condition
Condition
First line therapy for recurrence or metastatic postmenopausal breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of High dose Toremifene after failure of adjuvant therapy of Aromatase Inhibitor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response Rate
Key secondary outcomes
Clinical benefit, Progression-Free Survival, 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/day for at least 12 weeks until disease progression.
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.recurrence or metastatic breast cancer
2.post menopausal woman
3.ER+ and/or PgR+
4.measurable lesion except for bone metastasis
5.using Aromatase Inhibitor as adjuvant therapy for at least 1 year.
6.normal bone marrow function
Key exclusion criteria
1.brain metastasis
2.bilateral brest cancer
3.male breast cancer
4.severe allergy
5.severe complications
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuneo Imai |
Organization
Nagoya University of School of Medicine
Division name
Breast and Endocrine Surgery
Zip code
Address
65 tsurumai-cho showa-ku Nagoya city
TEL
052-744-2251
m-sawaki@aichi-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masataka Sawaki |
Organization
Nagoya University of School of Medicine
Division name
Breast and Endocrine Surgery
Zip code
Address
65 tsurumai-cho showa-ku Nagoya city
TEL
052-744-2251
Homepage URL
sawapi@qc4.so-net.ne.jp
Sponsor or person
Institute
Nagoya University of School of Medicine Breast and Endocrine Surgery
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
| 2006 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2005 | Year | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 09 | Month | 14 | Day |
Last modified on
| 2014 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000594
