UMIN-CTR Clinical Trial

Basic information
Public title	Study of Docetaxel followed by FEC as primary systemic chemotherapy for operable breast cancer (JBCRG-03)
Acronym	JBCRG-03(DOC-FEC as primary systemic chemotherapy)
Scientific Title	Study of Docetaxel followed by FEC as primary systemic chemotherapy for operable breast cancer (JBCRG-03)
Scientific Title:Acronym	JBCRG-03(DOC-FEC as primary systemic chemotherapy)
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effectg and safety of Docetaxel followed by FEC as primary systemic chmeotehrapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Pathological responce, safety
Key secondary outcomes	Clinical response, Breast conserving rate, Overall survival, 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	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	60 years-old >
Gender	Female
Key inclusion criteria	T1c-3N0M0, T1-3N1M0 No previous treatment for breast cancer Adequate organ function Written informed consent
Key exclusion criteria	Drug hypersensitivity Severe complication Inflammatory breast cancer Double cancer Bilateral breast cancer
Target sample size	130

Research contact person
Name of lead principal investigator	1st name Hiroji Middle name Last name Iwata
Organization	Aichi Cancer Center Hospital
Division name	Department of Breast Oncology
Zip code	464-8681
Address	1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan
TEL	052-762-6111
Email	hiwata@aichi-cc.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
Email	office@jbcrg.jp

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

Funding Source
Organization	Advanced Clinical Reseach Orginization (ACRO)
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	JBCRG
Address	9-4-3F, 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	2005 Year 11 Month 25 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/21719750/
Number of participants that the trial has enrolled	137
Results	Of the 132 patients assessable for pathologic response, 23% experienced a pCR and 6% had a near pCR (few remaining cancer cells), resulting in a quasi-pCR of 29%. Clinical RR following the initial DOC regimen was 64%. The overall clinical RR after completion of FEC was 79%. Breast-conserving surgery was performed in 79% of patients.
Results date posted	2021 Year 08 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2011 Year 07 Month 01 Day
Baseline Characteristics	Patients with operable primary breast cancer
Participant flow	4 cycles of DOC administered i.v. every 21 days were followed by 4 cycles of FEC administered i.v. on Day 1 every 21 days before surgery.
Adverse events	Neutropenia was the most common Grade 3/4 treatment-related AE and was observed in 44% and 60% of patients during DOC and FEC therapy, respectively.
Outcome measures	Primary endpoints: Pathological response, Safety Secondary endpoints: Clinical response Breast-conserving surgery rate
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2005 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date	2005 Year 10 Month 01 Day
Last follow-up date	2009 Year 07 Month 01 Day
Date of closure to data entry	2009 Year 09 Month 01 Day
Date trial data considered complete	2009 Year 10 Month 01 Day
Date analysis concluded	2009 Year 12 Month 01 Day

Other

Other related information

Presentations:The 15th Annual Meeting of the Japanese Breast Cancer Society(2007),The 16th Annual Meeting of the Japanese Breast Cancer Society(2008), 6hth EBCC Papers:Biomed Pharmacother (2005,Oct; 59 Suppl 2:S387-92), BIG News Letter (2006, 8(1), Breast Cancer (2006,13(1), p38-48), JJBC(2007, 22(5), p372-375), European J of Cancer Suppl.(2008,16(7), p121),Japanese Journal of Clinical Oncology(2011, 41: 867-875)

Management information
Registered date	2005 Year 11 Month 25 Day
Last modified on	2021 Year 08 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000368