A Study to Compare Eribulin Mesylate + Pertuzumab + Trastuzumab With Paclitaxel or Docetaxel + Pertuzumab + Trastuzumab

September 24, 2025 updated by: Japan Breast Cancer Research Group

A Phase III Clinical Study to Compare the Combination Therapy of Eribulin Mesylate + Pertuzumab + Trastuzumab With Paclitaxel or Docetaxel + Pertuzumab + Trastuzumab (EMERALD)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

446

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Kanagawa Cancer Center
    • Osaka
      • Osaka, Osaka, Japan, 540-0006
        • National Hospital Organization Osaka National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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. Presence of a measurable lesion not required
  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/mm 3 (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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A

Trastuzumab + pertuzumab + Taxane*

*Taxane is chosen from the following; Docetaxel or Paclitaxel
Drug: Pertuzumab
Every 3 weeks
Other Names:
  • Perjeta
Drug: Trastuzumab
Every 3 weeks
Other Names:
  • Herceptin
Drug: Docetaxel
Every 3 weeks
Other Names:
  • Taxotere
Drug: Paclitaxel
Every week
Other Names:
  • Taxol
Experimental: Arm B
Trastuzumab+ Pertuzumab + Eribulin
Drug: Pertuzumab
Every 3 weeks
Other Names:
  • Perjeta
Drug: Trastuzumab
Every 3 weeks
Other Names:
  • Herceptin
Drug: Eribulin
Administered for 2 weeks and is then stopped to be administered for 1 week
Other Names:
  • Halaven

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 5.75 years
Progression-free survival
5.75 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RR
Time Frame: 5.75 years
Response rate
5.75 years
DR
Time Frame: 5.75 years
Duration of response
5.75 years
OS
Time Frame: 6.25 years
Overall survival
6.25 years
PRO
Time Frame: 5.75 years
Patient-reported outcomes(Numbness & tingling)
5.75 years
Biomaker
Time Frame: 5.75 years
DNA mutation in the ctDNA and tumor tissue such as HER2,HER3, and PIK3CA
5.75 years
nMFS
Time Frame: 5.75 years
new Metastases free survival
5.75 years
TTF of the subsequent treatment
Time Frame: 5.75 years
Treatment duration of the following treatment
5.75 years
Safety
Time Frame: 5.75 years
  1. Incidence of infusion reactions and left ventricular dysfunction
  2. LVEF measurements during the study period
  3. Incidence and severity of adverse events and serious adverse events
  4. Abnormal laboratory test values
5.75 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Japan Breast Cancer Research Group

Collaborators

Eisai Co., Ltd.

Investigators

  • Principal Investigator: Toshinari Tamashita, MD, PhD, Kanagawa Cancer Center
  • Principal Investigator: Norikazu Masuda, MD, PhD, NHO Osaka National Hospital
  • Principal Investigator: Shigehira Saji, MD, PhD, Fukushima Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2017

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

August 1, 2017

First Submitted That Met QC Criteria

August 24, 2017

First Posted (Actual)

August 29, 2017

Study Record Updates

Last Update Posted (Estimated)

September 29, 2025

Last Update Submitted That Met QC Criteria

September 24, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JBCRG-M06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Pertuzumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe