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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017675
Receipt No. R000020489
Scientific Title A study of neoadjuvant nab-paclitaxel followed by FEC for luminal B-like (HER2-negative) and triple-negative breast cancer
Date of disclosure of the study information 2015/05/25
Last modified on 2018/01/05

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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
Registered date File name


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