UMIN-CTR Clinical Trial

Basic information
Public title	Validation study of FEC followed by docetaxel as preoperative chemotherapy in primary beast cancer (JBCRG-02')
Acronym	Validation study of FEC followed by docetaxel as preoperative chemotherapy in primary beast cancer (JBCRG-02')
Scientific Title	Validation study of FEC followed by docetaxel as preoperative chemotherapy in primary beast cancer (JBCRG-02')
Scientific Title:Acronym	Validation study of FEC followed by docetaxel as preoperative chemotherapy in primary beast cancer (JBCRG-02')
Region	Japan

Condition
Condition	Primary breast cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	validation of efficacy and safety of JBCRG-02
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Safety, clinical and pathological response
Key secondary outcomes	Breast-conserving rate, disease-free survival

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	Primary systemic chemotherapy: fluorouracil 500 mg/m2, epirubicin 100 mg/m2, cyclophosphamide 500 mg/m2, q3w x 4 cycles + Docetaxel 100 mg/m2, q3w x 4 cycles
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	60 years-old >
Gender	Female
Key inclusion criteria	Histologiccally-proven breast cancer T1c-3N0M0/T1-3N1M0 No prior therapy for breast cancer Performance status 0-1 Adequate hematologic, renal, hepatic and cardiac function Written informed consent
Key exclusion criteria	Hypersensitivity for drugs Serious coexisting illness Active double cancer Bilateral breast cancer Male breast cancer Pregnant or postpartum wemen
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Seigo Middle name Last name Nakamura
Organization	St Luke's International Hospital
Division name	Breast Center
Zip code	104-8560
Address	9-1 Akashi, Chuo-ku, Tokyo
TEL	03-3541-5151
Email	seigonak@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Katsumasa Middle name Last name Kuroi
Organization	JBCRG
Division name	Head office
Zip code	103-0016
Address	9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
TEL	03-6264-8873
Homepage URL	https://jbcrg.jp/
Email	office@jbcrg.jp

Sponsor
Institute	Japan Breast Cancer Reaserch Group (JBCRG)
Institute
Department

Funding Source
Organization	Advanced Clinical Reaserch Organization (ACRO)
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	JBCRG
Address	9-4 Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
Tel	03-6264-8873
Email	office@jbcrg.jp

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	2006 Year 02 Month 02 Day

Related information
URL releasing protocol
Publication of results	Published

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	2005 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date	2005 Year 12 Month 01 Day
Last follow-up date	2010 Year 12 Month 01 Day
Date of closure to data entry	2011 Year 06 Month 01 Day
Date trial data considered complete	2011 Year 12 Month 01 Day
Date analysis concluded	2012 Year 01 Month 01 Day

Other
Other related information	Presentation:14th&15th Annual meeting of Japanese Breast Cancer Society(2006&2007), 2nd OOTR(2005), 29th SABCS(2006) Paper: Biomed Pharmacother(2005, Oct;59 Suppl 2:S387-92), BIG News Letter(2006, 8(1)), Breast Cacer(2006, 13(1) p38-48), JJBC(2007,23(2), p111-117)

Management information
Registered date	2006 Year 02 Month 02 Day
Last modified on	2019 Year 11 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000410