UMIN-CTR Clinical Trial

Public title

Randomized phase II study of eribulin versus nab-paclitaxel in patients with relapsed HER2-negative breast cancer previously treated with anthracycline and peri-operative taxane

Acronym

EVA study

Scientific Title

Randomized phase II study of eribulin versus nab-paclitaxel in patients with relapsed HER2-negative breast cancer previously treated with anthracycline and peri-operative taxane

Scientific Title:Acronym

EVA study

Region

Japan

Condition

Breast Cancer relapsed after surgery

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate the efficacy of eribulin in comparison of nab-paclitaxel

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Progression-free survival

Key secondary outcomes

Overall response rate, overall survival, and safety

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

nab-paclitaxel

Interventions/Control_2

eribulin

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

1) histologically or cytologically proven breast cancer
2) relapsed after surgery
3) HER2 negative
4) patient with assessable lesion
5) prior peri-operative taxane
6) prior anthracycline
7) first- or second-line
8) appropriate period from prior therapy
21 days from chemotherapy
7 days from hormone therapy
14 days from radiotherapy
28 days from major surgery
14 days from minor surgery
9) PS (ECOG) 0-1
10) adequate organ function
neutrophil>=1,500/mm3
platelet>=100,000/mm3
hemoglobin>=9.0 g/dL
AST (GOT) <=100 IU/L (<=150 IU/L if liver metastases)
ALT (GPT) <=100 IU/L (<=150 IU/L if liver metastases)
T-Bil<=1.5 mg/dL
serum Cr<=1.5 mg/dL
SpO2>=94% (ambient air)
11) 20 years or older
12) Written informed consent
13) life expectancy>=90 days

Key exclusion criteria

1) prior eribulin and/or nab-paclitaxel
2) taxane for metastatic disease
3) <6monthd from last taxane administration
4) Effusions (pleural, pericardial effusion, ascites) requiring treatment
5) brain metastasis requiring treatment
6) >=grade 2 peripheral sensory neuropathy (CTCAE ver4.0)
7) clinically abnormal ECG
8) systemic infection
9) severe diabetes mellitus
10) interstitial pneumonia/pulmonary fibrosis apparent on chest Xp
11) active double cancer
12) severe psychosis
13) systemic corticosteroid
14) severe drug allergy
15) hypersensitivity for paclitaxel and/or albumin
16) positive HBs antigen
17) pregnant or lactating woman
18) other causes judged ineligible by attending physician

Target sample size

140

Name of lead principal investigator

1st name
Middle name
Last name	Yoichi Naito

Organization

National Cancer Center Hospital East

Division name

Department ofBreast and Medical Oncology

Zip code

Address

6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan

TEL

04-7133-1111

Email

Name of contact person

1st name
Middle name
Last name	Shinichiro Nakamura

Organization

West Japan Oncology Group

Division name

WJOG datacenter

Zip code

Address

Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN

TEL

06-6633-7400

Homepage URL

Email

datacenter@wjog.jp

Institute

West Japan Oncology Group

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2012

Year

08

Month

18

Day

Date of IRB

Anticipated trial start date

2012

Year

10

Month

09

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

09

Month

03

Day

Last modified on

2014

Year

04

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010382