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

NCT03264547 | Completed Phase 3 DMC

• 1 other identifier: JBCRG-M06
• Study Type: interventional
• Target: 446
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-free survival

  5.75 years

Secondary Outcomes (8)

• RR

  5.75 years

• DR

  5.75 years

• OS

  6.25 years

• PRO

  5.75 years

• Safety

  5.75 years

Study Arms (2)

Arm A

ACTIVE COMPARATOR

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

Drug: Pertuzumab; Drug: Trastuzumab; Drug: Docetaxel; Drug: Paclitaxel

Arm B

EXPERIMENTAL

Trastuzumab+ Pertuzumab + Eribulin

Drug: Pertuzumab; Drug: Trastuzumab; Drug: Eribulin

Interventions

Pertuzumab DRUG

Every 3 weeks

Also known as: Perjeta

Arm A; Arm B

Trastuzumab DRUG

Every 3 weeks

Also known as: Herceptin

Arm A; Arm B

Docetaxel DRUG

Every 3 weeks

Also known as: Taxotere

Arm A

Paclitaxel DRUG

Every week

Also known as: Taxol

Arm A

Eribulin DRUG

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

Also known as: Halaven

Arm B

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Japan Breast Cancer Research Group: lead
• Eisai Co., Ltd.: collaborator

Study Sites (2)

Kanagawa Cancer Center

Yokohama, Kanagawa, 241-8515, Japan

Location

National Hospital Organization Osaka National Hospital

Osaka, Osaka, 540-0006, Japan

Location

Related Publications (6)

• Baselga J, Cortes J, Kim SB, Im SA, Hegg R, Im YH, Roman L, Pedrini JL, Pienkowski T, Knott A, Clark E, Benyunes MC, Ross G, Swain SM; CLEOPATRA Study Group. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 2012 Jan 12;366(2):109-19. doi: 10.1056/NEJMoa1113216. Epub 2011 Dec 7.

  PMID: 22149875 BACKGROUND

• Cortes J, O'Shaughnessy J, Loesch D, Blum JL, Vahdat LT, Petrakova K, Chollet P, Manikas A, Dieras V, Delozier T, Vladimirov V, Cardoso F, Koh H, Bougnoux P, Dutcus CE, Seegobin S, Mir D, Meneses N, Wanders J, Twelves C; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) investigators. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011 Mar 12;377(9769):914-23. doi: 10.1016/S0140-6736(11)60070-6. Epub 2011 Mar 2.

  PMID: 21376385 BACKGROUND

• Kaufman PA, Awada A, Twelves C, Yelle L, Perez EA, Velikova G, Olivo MS, He Y, Dutcus CE, Cortes J. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol. 2015 Feb 20;33(6):594-601. doi: 10.1200/JCO.2013.52.4892. Epub 2015 Jan 20.

  PMID: 25605862 BACKGROUND

• Wilks S, Puhalla S, O'Shaughnessy J, Schwartzberg L, Berrak E, Song J, Cox D, Vahdat L. Phase 2, multicenter, single-arm study of eribulin mesylate with trastuzumab as first-line therapy for locally recurrent or metastatic HER2-positive breast cancer. Clin Breast Cancer. 2014 Dec;14(6):405-12. doi: 10.1016/j.clbc.2014.04.004. Epub 2014 Jun 2.

  PMID: 25024001 BACKGROUND

• Yamashita T, Saji S, Takano T, Naito Y, Tsuneizumi M, Yoshimura A, Takahashi M, Tsurutani J, Iwatani T, Kitada M, Tada H, Mori N, Higuchi T, Iwasa T, Araki K, Koizumi K, Hasegawa H, Uchida Y, Morita S, Masuda N. Trastuzumab-Pertuzumab Plus Eribulin or Taxane as First-Line Chemotherapy for Human Epidermal Growth Factor 2-Positive Locally Advanced/Metastatic Breast Cancer: The Randomized Noninferiority Phase III EMERALD Trial. J Clin Oncol. 2025 Apr 10;43(11):1302-1313. doi: 10.1200/JCO-24-01888. Epub 2025 Jan 9.

  PMID: 39787453 DERIVED

• Yamashita T, Masuda N, Saji S, Araki K, Ito Y, Takano T, Takahashi M, Tsurutani J, Koizumi K, Kitada M, Kojima Y, Sagara Y, Tada H, Iwasa T, Kadoya T, Iwatani T, Hasegawa H, Morita S, Ohno S. Trastuzumab, pertuzumab, and eribulin mesylate versus trastuzumab, pertuzumab, and a taxane as a first-line or second-line treatment for HER2-positive, locally advanced or metastatic breast cancer: study protocol for a randomized controlled, non-inferiority, phase III trial in Japan (JBCRG-M06/EMERALD). Trials. 2020 May 7;21(1):391. doi: 10.1186/s13063-020-04341-y.

  PMID: 32381018 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pertuzumab; Trastuzumab; Docetaxel; Paclitaxel; eribulin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 29, 2017
• Study Start: August 28, 2017
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)