UMIN-CTR Clinical Trial

Public title

A phase III clinical study to compare the combination therapy of eribulin mesylate + trastuzumab + pertuzumab with paclitaxel or Docetaxel + trastuzumab + pertuzumab

Acronym

JBCRG-M06 (EMERALD)

Scientific Title

A phase III clinical study to compare the combination therapy of eribulin mesylate + trastuzumab + pertuzumab with paclitaxel or Docetaxel + trastuzumab + pertuzumab

Scientific Title:Acronym

JBCRG-M06 (EMERALD)

Region

Japan

Condition

HER2-positive progressive-recurrent breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To verify that combination therapy with trastuzumab + pertuzumab + eribulin brings similar PFS and better QOL compared to trastuzumab + pertuzumab + taxane in advanced/recurrent HER2-positive breast cancer patients who have no medical history of chemotherapy except ado-trastuzumab emtansine

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase III

Primary outcomes

Progression-free survival: PFS

Key secondary outcomes

1.Response rate
2.Duration of response
3.Overall survival
4.Patient-reported outcomes
5.Safety
6.Biomaker
7.new Metastases free survival
8.Treatment duration of next treatment

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 not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Trastuzumab + pertuzumab + Taxane
Taxane is chosen from the following;
Docetaxel or Paclitaxel

Interventions/Control_2

Trastuzumab+ Pertuzumab + 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

70

years-old

>=

Gender

Female

Key inclusion criteria

1)Patients with breast cancer that is confirmed histologically or cytologically
2)Patients who are confirmed to be HER2 positive for the primary or a metastatic lesion at a participating medical institution
3)Patients with no medical history of treatment for advanced/recurrent cancer using a regimen of drugs including chemotherapeutics
4) >=6 months have passed since perioperative treatment with anticancer agents
5)The patient must have an evaluable lesion. (Measurable lesions are not necessary, but lesions that can confirm progress are essential)
6)Female aged 20-70 years old at the time of consent acquisition
7)Baseline left ventricular ejection fraction (LVEF) measured by ECHO or MUGA of >=50%
8)Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1
9)Patients who have maintained major organ functions, meeting all of the following criteria on a test within 28 days before enrollment. If there are multiple test results during this period, that obtained immediately before enrollment should be adopted.
(1)Neutrophil count: >=1,500/mm³
(2)Platelet count: >=100,000/mm³
(3)Hemoglobin: >=9.0 g/dL
(4)Total bilirubin: <=1.5 mg/dL
(5)AST (GOT), ALT (GPT): <=2.5 times the ULN (<=5 times in those with liver metastasis)
(6)Serum creatinine: <=1.5 mg/dL
10)Patients with a life expectancy of at least 6 months
11)Patient who submits written consent herself after receiving sufficient explanation about this study
12)Patients who can undergo QOL investigation

Key exclusion criteria

1)Patients planning to undergo radical surgery if they respond to a treatment
2)Patients who have non-hematological adverse events assessed as Grade >=3 in the Common Terminology Criteria for Adverse Events ver. 4.0 in the Japanese JCOG version (CTCAE v4.0-JCOG) at the time of enrollment
3)Patients who have symptomatic metastases to the central nervous system or whose symptoms are hard to control
4)Patients who have active double cancer
5)Patients who have poorly controlled hypertension, or unstable angina
6)Patients who have a past history of congestive heart failure assessed as Class ll or higher in the New York Heart Association (NYHA) classification, or clinically significant arrhythmia requiring treatment
7)Patients with a past history of myocardial infarction within 6 months before enrollment
8)Patients who are expected to undergo major surgical treatment or who had severe injury within 28 days before enrollment, or who require major surgical treatment during the study treatment period
9)Patients with interstitial pneumonia which is symptomatic or requires treatment
10)Pregnant women, those with a positive pregnancy test, and lactating women
11)Patients with active systemic infection (including HCV and HBV), or who are found to be HIV-positive
12)Patients with hypersensitivity against pertuzumab and trastuzumab
13)Patients whom the investigator consider unable or unwilling to follow the protocol requirements

Target sample size

480

Name of lead principal investigator

1st name	1)Toshinari 2)Norikazu 3)Shigehira
Middle name
Last name	1)Yamashita 2)Masuda 3)Saji

Organization

1)Kanagawa Cancer Center
2)National Hospital Organization Osaka Medical Center
3)Fukushima Medical University

Division name

1) Department of Breast and Endocrine Surgery 2) Surgery, Breast Oncology 3) Department of Medical Oncology

Zip code

241-8515

Address

1) 2-3-2 Nakao, Asahi-ku, Yokohama, Japan

TEL

045-520-2222

Email

tyamashita@kcch.jp

Name of contact person

1st name	Jun
Middle name
Last name	Fukase

Organization

Japan Breast Cancer Research Group (JBCRG)

Division name

Head Office

Zip code

103-0016

Address

9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo, Japan

TEL

03-6264-8873

Homepage URL

https://www.jbcrg.jp/

Email

office@jbcrg.jp

Institute

Japan Breast Cancer Research Group

Institute

Department

Personal name

Organization

Eisai Co., Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Eisai Co., Ltd

Name of secondary funder(s)

Organization

N/A

Address

N/A

Tel

N/A

Email

N/A

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

神奈川県立がんセンター(神奈川県)、大阪医療センター(大阪府)、福島県立医科大学(福島県)

Date of disclosure of the study information

2017

Year

06

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

446

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

No longer recruiting

Date of protocol fixation

2017

Year

06

Month

28

Day

Date of IRB

2017

Year

08

Month

02

Day

Anticipated trial start date

2017

Year

10

Month

23

Day

Last follow-up date

2024

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

06

Month

26

Day

Last modified on

2023

Year

01

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031805