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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001736
Receipt No. R000002019
Scientific Title Neo-adjuvant therapy with paclitaxel followed by FEC fluoraouracil, epirubicin and cyclophosphamide) for primary breast cancer(KBC-SG0801)
Date of disclosure of the study information 2009/02/27
Last modified on 2018/05/14

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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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