UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017675 |
|---|---|
| Receipt number | 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 12:20:27 |
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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
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
kbc@chotsg.com
Sponsor or person
Institute
Kyushu Breast Cancer Study Group (KBC-SG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020489
