UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001481 |
|---|---|
| Receipt number | R000001797 |
| Scientific Title | Open labelled multicenter randomized comparative trial of high-dose toremifene for non-steroidal aromatase inhibitor resistant breast cancer compared to exemestane |
| Date of disclosure of the study information | 2008/11/05 |
| Last modified on | 2014/02/20 16:05:14 |
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Basic information
Public title
Open labelled multicenter randomized comparative trial of high-dose toremifene for non-steroidal aromatase inhibitor resistant breast cancer compared to exemestane
Acronym
Randomized comparative trial of high-dose toremifene for non-steroidal aromatase inhibitor resistant breast cancer compared to exemestane
Scientific Title
Open labelled multicenter randomized comparative trial of high-dose toremifene for non-steroidal aromatase inhibitor resistant breast cancer compared to exemestane
Scientific Title:Acronym
Randomized comparative trial of high-dose toremifene for non-steroidal aromatase inhibitor resistant breast cancer compared to exemestane
Region
| Japan |
Condition
Condition
Advanced/recurrent breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison of efficacy and safety between 120mg toremifene-citrate and 25mg exemestane in the recurrent/advanced breast cancer patients with tumor which has relapsed after treatment of non-steriodal aromatase inhibitors
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
clinical benefit rate
Key secondary outcomes
response rate, time to progression, time to treatment failure, adverse events, presictive factor
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TOR: Toremifene (120mg) is orally administered once a day everyday.
Interventions/Control_2
EXE: Exemestane (25mg) is orally administered once a day everyday.
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. The case signed informed consent of the patients for the registration
2. The case confirmed by pathological diagnosis
3. postmenopausal women with breast cancer (not less than 30 year old)
4. The case who had progressive disease during or after the treatment of non-steroidal aromatase inhibitors
5. The case with measurable metastatic / recurrent site or evaluable bone metastasis
6. The case with ER positive and/or PgR positive
7. The case that survival more than six months is anticipated
8. The case with PS 0 or 1, additionally the case with PS 2 only by bone metastasis
9. The case with a satisfactory function of a heart/liver/kidney/bone marrow and to satisfy the next condition
Hb: more than 8g/dl
AST(GOT), ALT(GPT): Less than 2.5 times of the normal value upper limit of the institution
Key exclusion criteria
1. The case with active other malignancies
2. The case with past history of drug allergy or hypersensitivity
3. The case during pregnancy or lactation
4. The case with severe progressive situation with non-indication for the hormone therapy
5. The case judged inappropriate by physicians
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotaka Iwase |
Organization
Graduate School of Medical Sciences,
Kumamoto University
Division name
Department of Breast and Endocrine Surgery
Zip code
Address
1-1-1 Honjo, Chuo-ku Kumamoto
TEL
096-373-5521
hiwase@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayako Okabe |
Organization
Graduate School of Medical Sciences
Division name
Department of Breast and Endocrine Surgery
Zip code
Address
1-1-1 Honjo, Kumamoto
TEL
096-373-5521
Homepage URL
http://www2.kuh.kumamoto-u.ac.jp/breast/index.html
bsokabe@kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Breast and Endocrine Surgery
Graduate School of Medical Sciences, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Department of Breast and Endocrine Surgery
Graduate School of Medical Sciences, Kumamoto University
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 | 11 | Month | 05 | Day |
Related information
URL releasing protocol
http://www2.kuh.kumamoto-u.ac.jp/breast/index.html
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
On May 30th, 2010, 42 cases were registered with this trial.
On May, 2011, 67 cases were registered with this trial.
On Nov, 2011, 91 cases were registered with this trial.
On May 2013, one of the results was published in BMC cancer.
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
No longer recruiting
Date of protocol fixation
| 2008 | Year | 10 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 04 | Month | 30 | Day |
Other
Other related information
Follow-up analysis has been done.
Management information
Registered date
| 2008 | Year | 11 | Month | 04 | Day |
Last modified on
| 2014 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001797
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
