UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017382
Receipt number R000020170
Scientific Title A Phase II trial of nab-paclitaxel followed by EC as neoadjuvant chemotherapy for resectable breast cancer.
Date of disclosure of the study information 2015/05/01
Last modified on 2015/05/01 19:45:32

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Basic information

Public title

A Phase II trial of nab-paclitaxel followed by EC as neoadjuvant chemotherapy for resectable breast cancer.

Acronym

Neo-ABEC trial

Scientific Title

A Phase II trial of nab-paclitaxel followed by EC as neoadjuvant chemotherapy for resectable breast cancer.

Scientific Title:Acronym

Neo-ABEC trial

Region

Japan


Condition

Condition

breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy and safety of tri-weekly nab-paclitaxel followed by EC for resectable 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 Rate

Key secondary outcomes

Overall response rate
Safety
Breast conservation rate
Disease-free survival


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

Triweekly nab-paclitaxel followed by EC as Neoadjuvant chemotherapy.Nab-paclitaxel regimen 260mg/m2 iv day 1
Q3weeks of each 4 cycles.EC regimen Epirubicin 90mg/m2 iv day 1.Cyclophosphamide 600mg/m2 iv day 1 Q3weeks of each 4 cycle.

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

75 years-old >

Gender

Female

Key inclusion criteria

Female resectable breast cancer (T1c-3N0-2M0)
Histologically confirmed invasive breast cancer by biopsy.Evaluated ER and PgR status by IHC.
Evaluated ER and PgR status by FISH.20 to 79 years old at diagnosis.
Adequate major organ function.
LVEF > 50% (by MUGA or ECHO).QTc < 470mec (by ECG).
Performance status(ECOG) should be 0 or 1. Written informed consent.

Key exclusion criteria

History of drug-hypersensitivity.
No previous treatments for breast cancer (within 5 years) .
Active double cancer.
Synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS).
Male patient.
Infection or suspected infection.
Serious cardiac disorder or preexisting cardiac disease.
Uncontrolled diabetes.
Gastrointestinal ulceration or gastrointestinal bleeding
Current pregnancy and lactation, or possibility of pregnancy.
Ineligible based on decision of an investigator.
preexisting cardiac disease.
Uncontrolled diabetes.
Gastrointestinal ulceration or gastrointestinal bleeding.
Current pregnancy and lactation, or possibility of pregnancy.
Ineligible based on decision of an investigator.

Target sample size

36


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takahiro Okamoto

Organization

Tokyo Women's Medical University

Division name

Department of Endocrine Surgery

Zip code


Address

8-1, Kawadachou, Shinjuku-ku, Tokyo, Japan.

TEL

+81-3-3353-8111

Email

akko-s@mth.biglobe.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akiko Sakamoto

Organization

Tokyo Women's Medical University

Division name

Department of Endocrine Surgery

Zip code


Address

8-1, Kawadachou, Shinjuku-ku, Tokyo, Japan.

TEL

+81-3-3353-8

Homepage URL


Email

akko-s@mth.biglobe.ne.jp


Sponsor or person

Institute

Tokyo Women's Medical University,Department of endocrine surgery

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

東京女子医科大学病院(東京都)


Other administrative information

Date of disclosure of the study information

2015 Year 05 Month 01 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

Open public recruiting

Date of protocol fixation

2012 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 06 Month 01 Day

Last follow-up date

2018 Year 06 Month 30 Day

Date of closure to data entry

2018 Year 08 Month 31 Day

Date trial data considered complete

2018 Year 09 Month 30 Day

Date analysis concluded

2018 Year 10 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 05 Month 01 Day

Last modified on

2015 Year 05 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020170


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name