UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002867 |
|---|---|
| Receipt number | R000003442 |
| Scientific Title | Effect of High-dose Toremifene for premenopausal metastatic breast cancer |
| Date of disclosure of the study information | 2009/12/24 |
| Last modified on | 2009/12/09 21:29:51 |
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Basic information
Public title
Effect of High-dose Toremifene
for premenopausal metastatic breast cancer
Acronym
Multi04 trial
Scientific Title
Effect of High-dose Toremifene
for premenopausal metastatic breast cancer
Scientific Title:Acronym
Multi04 trial
Region
| Japan |
Condition
Condition
premenopausal metastatic breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine effect of high-dose Toremifene for premenopausal metastatic breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Clinical Benefit
Key secondary outcomes
clinical response rate
Time to progression
Time to treatment failure
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
a combination of a gonadotropin-releasing hormone agonist goserelin or Leuprorelin Acetate, and a high-dose toremifene 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
premenopausal women with metastatic or locally advanced breast cancer who had previously been treated with gonadotropin-releasing hormone agonist and tamoxifen or aromatase inhibitor
Key exclusion criteria
Patients have an inadequte organ function. Patients who have had any previous or concomitant malignancy. Patients who have had any other non-malignant systemic diseases (cardiovascular, renal lung, etc. ) that would prevent follow-up
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuaki Sato |
Organization
Niigata Cancer Center Hospital
Division name
Department of Surgery
Zip code
Address
2-15-3, Kawagishi-cho, Chuo-ku, Niigata, Niigata 951-8566, Japan
TEL
81-25-266-5111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuaki Sato |
Organization
Niigata Cancer Center Hospital
Division name
Department of Surgery
Zip code
Address
2-15-3, Kawagishi-cho,Chuo-ku, Niigata, Niigata 951-8566, Japan
TEL
81-25-266-5111
Homepage URL
nobus@niigata-cc.jp
Sponsor or person
Institute
Multi Hormone Study Group
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
新潟県立がんセンター(新潟県）、帝京大学医学部附属病院外科（東京都）、新宿ブレストセンター（東京都）、ブレストピアなんば病院（宮崎県）、埼玉県立がんセンター（埼玉県）
岡山大学医学部・歯学部附属病院（岡山県）、熊本市民病院（熊本県）北九州市立医療センター（福岡県）、みやうちクリニック（兵庫県）、群馬県立がんセンター（群馬県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 09 | Day |
Last modified on
| 2009 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003442
