UMIN-CTR Clinical Trial

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