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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017033
Receipt No. R000019752
Scientific Title A phase II neoadjuvant trial of sequential weekly nab-paclitaxel(nanoparticle albumin-bound paclitaxel) (abraxane) in HER2-negative patients, followed by 5-fluorouracil/ epirubicine/ cyclophosphamide (FEC) in operable breast cancer
Date of disclosure of the study information 2015/04/03
Last modified on 2015/04/03

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Basic information
Public title A phase II neoadjuvant trial of sequential weekly nab-paclitaxel(nanoparticle albumin-bound paclitaxel) (abraxane) in HER2-negative patients, followed by 5-fluorouracil/ epirubicine/ cyclophosphamide (FEC) in operable breast cancer
Acronym neo-WABI BC
Scientific Title A phase II neoadjuvant trial of sequential weekly nab-paclitaxel(nanoparticle albumin-bound paclitaxel) (abraxane) in HER2-negative patients, followed by 5-fluorouracil/ epirubicine/ cyclophosphamide (FEC) in operable breast cancer
Scientific Title:Acronym neo-WABI BC
Region
Japan

Condition
Condition Breast Cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of neoadjyuvant sequential weekly nab-paclitaxel in HER2-negative patients, followed by 5-fluorouracil/ epirubicine/ cyclophosphamide (FEC) in operable breast cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes pathological Complete Response (pCR)
Key secondary outcomes Response Rate (RR)
Safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 neoadjyuvant sequential weekly nab-paclitaxel in HER2-negative patients, followed by 5-Fluorouracil/ epirubicine/ cyclophosphamide (FEC)
weekly nab-paclitaxel 100mg/mm2 4cycle
FEC 4cycle
5-Fluorouracil 500mg/mm2 day1 q3w
Epirubicine 100mg/mm2 day1 q3w
Cyclophosphamide 500mg/mm2 day1 q3w
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

Not applicable
Gender Female
Key inclusion criteria 1) Histologically confirmed invasive breast cancer
2) operable primary breast cancer (cT1c-3N0M0/cT1-3N1M0)
3)Evaluated ER and PgR status by IHC
4)Evaluated HER2(-) by IHC/ FISH
5)Age > 20 years
6)evaluable lesion
7)Adequate major organ function
(1)WBC >3,000/mm3, Neu> 1,500/mm3
(2)Plt> 100,000/mm3
(3)Hb> 9.0 g/dL
(4)AST/ALT < ULT 2.5
(5)Bil < ULT 1.5
(6)Cr< ULT 1.5
(7)ECG< ULT
8)Performance Status (ECOG) 0 or 1
9)Signed written informed consent
Key exclusion criteria 1)History of drug-hypersensitivity.
2) Evaluated HER2(+) by IHC/FISH.
3) Active double cancer.
4)Synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS)
5) Male patient.
6) Infection or suspected infection.
7) Abnormal ECG or serious cardiac disorder.
(1)History of congestive cardiac failure.(NYHA class III/IV))
8) Complication needed hospitalization.
9) Mental disease with difficulty of taking part in this study.
10) Administration of steroid.
11) HBV related marker (+).
12)Gastrointestinal bleeding.
13)Current pregnancy and lactation, or possibility of pregnancy.
14)Ineligible based on decision of an investigator.
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takako Kamio
Organization Tokyo Women's Medical University
Division name Department of Surgery II
Zip code
Address 8-1, Kawada-cho, Shinjyuku-ku, Tokyo, Japan
TEL 03-3353-8111
Email ein2002@surg2.twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiichiro Noguchi
Organization Tokyo Women's Medical University
Division name Department of Surgery II
Zip code
Address 8-1, Kawada-cho, Shinjyuku-ku, Tokyo, Japan
TEL 03-3353-8111
Homepage URL
Email ein2002@surg2.twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Department of Surgery II
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
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

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 03 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 Enrolling by invitation
Date of protocol fixation
2013 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 15 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 04 Month 30 Day
Date trial data considered complete
2017 Year 05 Month 31 Day
Date analysis concluded
2017 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 04 Month 03 Day
Last modified on
2015 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019752

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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