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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000489
Receipt No. R000000594
Scientific Title Study of High dose Toremifene for metastatic breast cancer after failure of adjuvant therapy of Aromatase Inhibitor
Date of disclosure of the study information 2006/10/01
Last modified on 2014/05/07

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Basic information
Public title Study of High dose Toremifene for metastatic breast cancer after failure of adjuvant therapy of Aromatase Inhibitor
Acronym Study of High dose Toremifene for metastatic breast cancer after failure of adjuvant therapy of Aromatase Inhibitor
Scientific Title Study of High dose Toremifene for metastatic breast cancer after failure of adjuvant therapy of Aromatase Inhibitor
Scientific Title:Acronym Study of High dose Toremifene for metastatic breast cancer after failure of adjuvant therapy of Aromatase Inhibitor
Region
Japan

Condition
Condition First line therapy for recurrence or metastatic postmenopausal breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Efficacy and safety of High dose Toremifene after failure of adjuvant therapy of Aromatase Inhibitor
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response Rate
Key secondary outcomes Clinical benefit, Progression-Free Survival, 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 Toremifene 120mg/day for at least 12 weeks 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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1.recurrence or metastatic breast cancer
2.post menopausal woman
3.ER+ and/or PgR+
4.measurable lesion except for bone metastasis
5.using Aromatase Inhibitor as adjuvant therapy for at least 1 year.
6.normal bone marrow function

Key exclusion criteria 1.brain metastasis
2.bilateral brest cancer
3.male breast cancer
4.severe allergy
5.severe complications
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuneo Imai
Organization Nagoya University of School of Medicine
Division name Breast and Endocrine Surgery
Zip code
Address 65 tsurumai-cho showa-ku Nagoya city
TEL 052-744-2251
Email m-sawaki@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masataka Sawaki
Organization Nagoya University of School of Medicine
Division name Breast and Endocrine Surgery
Zip code
Address 65 tsurumai-cho showa-ku Nagoya city
TEL 052-744-2251
Homepage URL
Email sawapi@qc4.so-net.ne.jp

Sponsor
Institute Nagoya University of School of Medicine Breast and Endocrine Surgery
Institute
Department

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

Other administrative information
Date of disclosure of the study information
2006 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2005 Year 07 Month 17 Day
Date of IRB
Anticipated trial start date
2005 Year 08 Month 01 Day
Last follow-up date
2011 Year 08 Month 01 Day
Date of closure to data entry
2011 Year 08 Month 01 Day
Date trial data considered complete
2011 Year 08 Month 01 Day
Date analysis concluded
2011 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 09 Month 14 Day
Last modified on
2014 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000594

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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