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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003091
Receipt No. R000003752
Scientific Title A pilot study of neoajuvant fluorouracil, epirubicin and cyclophosphamide followed by paclitaxel plus high dose toremifene in women with node positive or high-risk breast cancer.
Date of disclosure of the study information 2010/01/26
Last modified on 2010/01/26

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Basic information
Public title A pilot study of neoajuvant fluorouracil, epirubicin and cyclophosphamide followed by paclitaxel plus high dose toremifene in women with node positive or high-risk breast cancer.
Acronym Neoajuvant FEC followed by paclitaxel plus high dose toremifene in women with node positive or high-risk breast cancer.
Scientific Title A pilot study of neoajuvant fluorouracil, epirubicin and cyclophosphamide followed by paclitaxel plus high dose toremifene in women with node positive or high-risk breast cancer.
Scientific Title:Acronym Neoajuvant FEC followed by paclitaxel plus high dose toremifene in women with node positive or high-risk breast cancer.
Region
Japan

Condition
Condition Primari breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Study of pathological response in neoajuvant FEC followed by paclitaxel plus high dose toremifene in women with node positive and high-risk breast cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes pathological response rate.
Key secondary outcomes clinila response rate, adverse events, breast concerving rate.

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
30 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1.Case signedinformed consent of the patients for the registration
2.Case confirmed by pathological diagnosis
3.Postmenopausal women with breast cancer
4.Node positive, high-risk, stage II breast cancer
5.Case that survival more than 6 months is anticipated
6.Case with PS 0 or 1
7.Case with measurable primary lesions
8.Case with a satisfactory function of a heart/liver/kidney/bone marrow ant 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
WBC:more than 4000/mm3
Plt:more than 100000/mm3
TB:less than 1.5mg/dl
Crea:less than 1.5 times of the normal value upper limit of the institution
Key exclusion criteria 1.Case with active other malignancies
2.Case with past history of drug allergy or hypersensitivity
3.Case during pregnancy or lactation
4.Case with adverse myelosuppression
5.Case with infectious disease
6.Case with inflammatory breast cancer
7.Case with metastatic breast cancer
8.Case judged inappropriate by physicians
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tohru Ohtake
Organization Fukushima Medical University School of Medicine
Division name Department of Breast Surgery
Zip code
Address 1 Hikariga-oka, Fukushima
TEL 024-547-1259
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuko Kawasaki
Organization Fukushima Medical University School of Medicine
Division name Department of Breast Surgery
Zip code
Address 1 Hikariga-oka, Fukushima
TEL 024-547-1259
Homepage URL
Email

Sponsor
Institute Department of Breast Surgery, Fukushima Medical University School of Medicine
Institute
Department

Funding Source
Organization Department of Breast Surgery, Fukushima Medical University School of Medicine
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 公立大学法人福島県立医科大学附属病院(福島県)

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 26 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 09 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2012 Year 11 Month 01 Day
Date of closure to data entry
2012 Year 11 Month 01 Day
Date trial data considered complete
2012 Year 11 Month 01 Day
Date analysis concluded
2012 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 01 Month 26 Day
Last modified on
2010 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003752

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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