UMIN-CTR Clinical Trial

Basic information
Public title	Neo-adjuvant therapy with paclitaxel followed by FEC fluoraouracil, epirubicin and cyclophosphamide) for primary breast cancer(KBC-SG0801)
Acronym	Neo-adjuvant therapy with paclitaxel followed by FEC fluoraouracil, epirubicin and cyclophosphamide) for primary breast cancer(KBC-SG0801)
Scientific Title	Neo-adjuvant therapy with paclitaxel followed by FEC fluoraouracil, epirubicin and cyclophosphamide) for primary breast cancer(KBC-SG0801)
Scientific Title:Acronym	Neo-adjuvant therapy with paclitaxel followed by FEC fluoraouracil, epirubicin and cyclophosphamide) for primary breast cancer(KBC-SG0801)
Region	Japan

Condition
Condition	Primary breast cancer
Classification by specialty	Medicine in general Surgery in general Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Clinical & pathological response and safety profile of neoadjuvant chemotherapy consisting of sequential treatment with paclitaxel monotherapy followed by FEC regimen for patients with primary breast cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Pathological complete response rate
Key secondary outcomes	Safety Clinical efficacy Overall survival Disease free survival Breast-conserving 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	Paclitaxel 80mg/m2 every week for 12 cycles. 5-FU 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2 on day 1, every 3 weeks for 4 cycles. Operation is to be offered to the patients with breast cancer as a curative intent within 2 months after neoadjuvant chemotherapy.
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	1.Histologicaly-proven primary resectable breast cancer with a tumor size of >=1cm and clinical stage of <=IIIA 2. No history of chemotherapy 3. No history of surgery, radiotherapy, hormonal therapy against breast cancer 4. ECOG PS 0, 1 5. Sufficient organ function 6. Written informed consent
Key exclusion criteria	1. Severe medical conditions 2. Suspected infectious disease 3. Alergy to clemohol EL 4. Severe peripheral neuropathy 5. Pregnant or lactating women
Target sample size	32

Research contact person
Name of lead principal investigator	1st name Middle name Last name Maki Tanaka
Organization	Kurume Daiichi Social Insurance Hospital
Division name	Surgery
Zip code
Address	21 Kushihara-Cho, Kurume
TEL	0942-33-1211
Email	maki@tanaka.name

Public contact
Name of contact person	1st name Middle name Last name Kazuo Tamura
Organization	Kyushu Breast Cancer Study Group
Division name	Executive office
Zip code
Address	1-8-17-204, Watanabe-dori, Chuo-ku, Fukuoka
TEL	092-406-4166
Homepage URL	http://www.chotsg.com
Email	npo@chotsg.com

Sponsor
Institute	Kyushu Breast Cancer Study Group
Institute
Department

Funding Source
Organization	Non-profit Organization Clinical Hematology/Oncology Study Group
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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	2009 Year 02 Month 27 Day

Related information
URL releasing protocol	http://www.chotsg.com
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	Completed
Date of protocol fixation	2008 Year 06 Month 18 Day
Date of IRB
Anticipated trial start date	2008 Year 09 Month 01 Day
Last follow-up date	2015 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2009 Year 02 Month 25 Day
Last modified on	2018 Year 05 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002019

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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