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Completed

NCT Number: NCT03264547

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

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

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Key information

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Kanagawa Cancer Center, Yokohama, Kanagawa, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with breast cancer that is confirmed histologically or cytologically
  • Patients who are confirmed to be HER2 positive for the primary or a metastatic lesion at a participating medical institution
  • Patients with no medical history of treatment for advanced/recurrent cancer using a regimen of drugs including chemotherapeutics
  • >=6 months have passed since perioperative treatment with anticancer agents
  • Presence of a measurable lesion not required
  • Female aged 20-70 years old at the time of consent acquisition
  • Baseline left ventricular ejection fraction (LVEF) measured by ECHO or MUGA of >=50%
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1
  • 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

  • Patients planning to undergo radical surgery if they respond to a treatment
  • 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
  • Patients who have symptomatic metastases to the central nervous system or whose symptoms are hard to control
  • Patients who have active double cancer
  • Patients who have poorly controlled hypertension, or unstable angina
  • 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
  • Patients with a past history of myocardial infarction within 6 months before enrollment
  • 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
  • Patients with interstitial pneumonia which is symptomatic or requires treatment
  • Pregnant women, those with a positive pregnancy test, and lactating women
  • Patients with active systemic infection (including HCV and HBV), or who are found to be HIV-positive
  • Patients with hypersensitivity against pertuzumab and trastuzumab
  • Patients whom the investigator consider unable or unwilling to follow the protocol requirements

Treatment and study plan

Pertuzumab

Drug

Every 3 weeks

Other names: Perjeta

Trastuzumab

Drug

Every 3 weeks

Other names: Herceptin

docetaxel

Drug

Every 3 weeks

Other names: Taxotere

paclitaxel

Drug

Every week

Other names: Taxol

Eribulin

Drug

Administered for 2 weeks and is then stopped to be administered for 1 week

Other names: Halaven

Primary outcomes

  1. PFS

    Time frame: 5.75 years

    Progression-free survival

Secondary outcomes

  1. RR

    Time frame: 5.75 years

    Response rate

  2. DR

    Time frame: 5.75 years

    Duration of response

  3. OS

    Time frame: 6.25 years

    Overall survival

  4. PRO

    Time frame: 5.75 years

    Patient-reported outcomes(Numbness & tingling)

  5. Safety

    Time frame: 5.75 years

    • Incidence of infusion reactions and left ventricular dysfunction
    • LVEF measurements during the study period
    • Incidence and severity of adverse events and serious adverse events
    • Abnormal laboratory test values
  6. Biomaker

    Time frame: 5.75 years

    DNA mutation in the ctDNA and tumor tissue such as HER2,HER3, and PIK3CA

  7. nMFS

    Time frame: 5.75 years

    new Metastases free survival

  8. TTF of the subsequent treatment

    Time frame: 5.75 years

    Treatment duration of the following treatment

Sponsors and collaborators

Lead sponsor

Japan Breast Cancer Research Group

Other

Collaborators

  • Eisai Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Aug 29, 2017
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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