UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010087
Receipt number 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 09:18:01

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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 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


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

Value
https://center6.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