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

Email



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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name