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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003178
Receipt No. 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

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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
Email

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
Email sho_ohtani@hotmail.com

Sponsor
Institute Hiroshima Breast Cancer Study Group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003798

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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