UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017033 |
|---|---|
| Receipt number | 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 17:07:36 |
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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
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
ein2002@surg2.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Department of Surgery II
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019752
