UMIN-CTR Clinical Trial

Basic information
Public title	A study of neoadjuvant nab-paclitaxel followed by FEC for luminal B-like (HER2-negative) and triple-negative breast cancer
Acronym	A study of neoadjuvant nab-paclitaxel followed by FEC for HER2-negative breast cancer
Scientific Title	A study of neoadjuvant nab-paclitaxel followed by FEC for luminal B-like (HER2-negative) and triple-negative breast cancer
Scientific Title:Acronym	A study of neoadjuvant nab-paclitaxel followed by FEC for HER2-negative breast cancer
Region	Japan

Condition
Condition	Luminal B-like (HER2-negative) or triple-negative operable breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the efficacy of neoadjuvant nab-paclitaxel followed by FEC and is to fined predictive markers for neoadjuvant chemotherapy and predictive factor for patients after neoadjuvant chemotherapy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Pathological complete response rate based on subtype
Key secondary outcomes	Breast conserving rates, response rates, safety, disease-free survival, overall survival, response rates of nab-paclitaxel,safety of nab-paclitaxel and identification of predictive factors for neoadjuvant chemotherapy and prognostic factors for patients after neoajuvant chemotherapy

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	Four cycles of nab-paclitaxel 260 mg/m2 every 3 weeks followed by 4 cycles of FEC (5-FU 500 mg/m2, Epirubicin 100 mg/m2, cyclophosphamide 500 mg/m2) every 3 weeks
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	70 years-old >
Gender	Female
Key inclusion criteria	1) Pathologically confirmed breast cancer 2) Clinical T1-3, N0-2, M0 and operable breast cancer after neoadjuvant chemotherapy 3) Luminal B-like(HER2-negative) or Triple-negative breast cancer 4) 20 years old and more than 20 years old, and less than 70 years old 5) mesurable disease (RECIST ver 1.1) 6) No any previous treatment for breast cancer 7) Performance status 0-1 8) keeping majour organ function with all condition below within 2 weeks before enrollment WBC, > 4000/mm3 and < 12,000 Neutropil, > 2000/mm3 platelets, > 100,000/mm3 Hb 10.0 g/dl ALT and AST, within 2x UNL T-bil, < 1.5 mg/dl Cr, < 1.5 mg/dl ECG, within normal limit (no severe arrythmia) UCG and MUGA scan, LVEF < 55% 9) indication for neoajuvant chemotherapy 10) Submission of needle biopsy sample before treatment and surgical specimen after neoajuvant chemotherapy and written informed consent
Key exclusion criteria	1) clinically important cardiac disorder and past history of this 2) Severe medical disorders (uncontrolled DM, hypertension, renal failure, liver failure, clinically significant infection and mental disorders) 3) pregnant and nursing female 4) active double cancer 5) lung fibrosis and intestinal pneumonisa 6) allergy reaction for drugs is using in this study 7) Others
Target sample size	94

Research contact person
Name of lead principal investigator	1st name Middle name Last name YUTAKA YAMAMOTO
Organization	Graduate shool of medical sciences, Kumamoto University
Division name	Department of Breast and Endocrine Surgery
Zip code
Address	1-1-1, Chuo-ku, , Kumamoto,860-8556, Japan
TEL	81-96-373-5521
Email	ys-yama@triton.ocn.ne.jp

Public contact
Name of contact person	1st name Middle name Last name Kazuo Tamura
Organization	Clinical Hematology Oncology Treatment Study Group
Division name	Kyushu Breast Cancer Study Group
Zip code
Address	1-8-17-204, Watanabe douri, Chuo-ku, Fukuoka, 810-0004, Japan
TEL	81-92-406-4166
Homepage URL	http://www.chotsg.com/kbc-sg/index.html
Email	kbc@chotsg.com

Sponsor
Institute	Kyushu Breast Cancer Study Group (KBC-SG)
Institute
Department

Funding Source
Organization	Kyushu Breast Cancer Study Group (KBC-SG)
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	熊本大学医学部附属病院等

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 25 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	No longer recruiting
Date of protocol fixation	2014 Year 07 Month 03 Day
Date of IRB
Anticipated trial start date	2014 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 05 Month 25 Day
Last modified on	2018 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020489

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
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