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

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 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


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

Value
https://center6.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