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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010087
Receipt No. R000010802
Scientific Title Randomized Comparative Trial of High-dose FARESTON for Aromatase Inhibitor resistant breast cancer compared to Faslodex
Date of disclosure of the study information 2013/02/22
Last modified on 2015/09/20

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Basic information
Public title Randomized Comparative Trial of High-dose FARESTON for Aromatase Inhibitor resistant breast cancer compared to Faslodex
Acronym HI-FAIR fx Study
Scientific Title Randomized Comparative Trial of High-dose FARESTON for Aromatase Inhibitor resistant breast cancer compared to Faslodex
Scientific Title:Acronym HI-FAIR fx Study
Region
Japan

Condition
Condition Recurrent/advanced breast cancer patients with tumor which has relapsed after treatment of aromatase inhibitors
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Comparison of efficacy and safety between 120mg toremifene citrate and 500mg fulvestrant in the recurrent 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
Developmental phase

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 Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
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 FUL: Fulvestrant (500mg) is intramuscular injected, day 1, day 15, day 28, followed by every 28 days.
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 104

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 +81-96-373-5521
Email hiwase@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yutaka Yamamoto
Organization Kumamoto University Hospital
Division name Department of Breast Cancer Molecular Trageting Therapy
Zip code
Address 1-1-1 Honjo, Chuo-ku Kumamoto
TEL +81-96-373-5521
Homepage URL http://www2.kuh.kumamoto-u.ac.jp/breast/index.html
Email ys-yama@triton.ocn.ne.jp

Sponsor
Institute Department of Breast and Endocrine Surgery
Graduate School of Medical Sciences, Kumamoto University
Institute
Department

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
Email

Secondary IDs
Secondary IDs YES
Study ID_1 1517
Org. issuing International ID_1 Faculty of Life Sciences, Kumamoto University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 熊本大学医学部附属病院(熊本県)、東京都立駒込病院(東京都)、横浜市立大学医療センター(神奈川県)、横浜労災病院(神奈川)、愛知県がんセンター中央病院(愛知県)、名古屋市立大学付属病院(愛知県)、福山市民病院(広島)

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 22 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 No longer recruiting
Date of protocol fixation
2012 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 29 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 05 Month 30 Day
Date trial data considered complete
2016 Year 07 Month 31 Day
Date analysis concluded
2016 Year 08 Month 15 Day

Other
Other related information

Management information
Registered date
2013 Year 02 Month 20 Day
Last modified on
2015 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010802

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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