UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003178 |
|---|---|
| Receipt number | R000003798 |
| Scientific Title | High-Dose TOREMIFENE for non-steroidal AI failure |
| Date of disclosure of the study information | 2010/02/13 |
| Last modified on | 2018/09/18 23:10:01 |
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Basic information
Public title
High-Dose TOREMIFENE for non-steroidal AI failure
Acronym
HI-TORE Study
Scientific Title
High-Dose TOREMIFENE for non-steroidal AI failure
Scientific Title:Acronym
HI-TORE Study
Region
| Japan |
Condition
Condition
Recurrent breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of high-dose tremifene for non-steroidal aromatase inhibitor failure postmenopausal breast cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
.Clinical benefit
.Response Rate (CR, PR)
Key secondary outcomes
.TTP(Time to progression)
.TTF(Time to treatment failure)
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
high-dose toremifene 120mg/body
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. Case confirmed by pathological diagnosis.
2. Postmenopausal women with breast cancer by mastectomy or breast conserving surgery.
3. Recurrent breast cancer patients who are taking anastorozole or letrozole as an adjuvant therapy.
4. Recurrent breast cancer patients who have finished anastorozole or letrozole as an adjuvant therapy less than 1 year ago. 5. Case with measurable primary lesions.
6. Case with positive ER or PgR.
7. Case with PS 0 or 1.
8. Case with a satisfactory function of a heart liver kidney bone marrow ant to satisfy the next condition.
9. Case stopped anastorozole or letrozole more than 2 weeks ago.
10. Case that last menstration was observed more than 1 year ago. 11. Case that survival more than 3 months is anticipated.
12. Case signedinformed consent of the patients for the registration.
Key exclusion criteria
(1)Contraindication case for toremifene.
(2)Case with inflammatory breast cancer or bilateral breast cancer.
(3)Case with active other malignancies.
(4)Case with life-threatening metastasis.
(5)Case with past history of drug allergy or hypersensitivity.
(6)Case with past use of anti-estrogen drug.
(7)Case judged inappropriate by physicians.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoichiro Ohtani |
Organization
Hiroshima City Hospital
Division name
Department of Breast surgery
Zip code
Address
7-33, Motomachi, Naka-ku, Hiroshima
TEL
082-221-2291
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shoichiro Ohtani |
Organization
Hiroshima Breast Cancer Study Group
Division name
Hiroshima Cancer Support
Zip code
Address
1-20, Honkawa-cho, Naka-ku, Hiroshima
TEL
0825443770
Homepage URL
http://www.ac.auone-net.jp/~hcancer/down.htm
sho_ohtani@hotmail.com
Sponsor or person
Institute
Hiroshima Breast Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
Hiroshima Breat Cancer Study Group
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
Hiroshima Breast Cancer Study Group
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 13 | 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
| 2009 | Year | 11 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 13 | Day |
Last modified on
| 2018 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003798
