UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003091 |
|---|---|
| Receipt number | 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 | 2019/10/17 08:10:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Sponsor or person
Institute
Department of Breast Surgery, Fukushima Medical University School of Medicine
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2009 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2011 | Year | 02 | Month | 22 | Day |
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
| 2019 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.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 |
