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AzTrials

Breast CancerPhase 3NCT03264547

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

A Phase 3 study testing Pertuzumab, Trastuzumab and Docetaxel in people with Breast Cancer, run by Japan Breast Cancer Research Group at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 20 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Pertuzumab, Trastuzumab and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
446 participants
Where
2 sitesJapan
Study dates
28 Aug 2017to 31 Dec 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.
  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • National Hospital Organization Osaka National Hospital

    Osaka, Osaka, 540-0006

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

About this study

Official title: 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

Conditions
Breast Cancer
Being tested
Pertuzumab, Trastuzumab, Docetaxel, Paclitaxel, Eribulin
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PertuzumabDrug

    Also called Perjeta

    Every 3 weeks

  • TrastuzumabDrug

    Also called Herceptin

    Every 3 weeks

  • DocetaxelDrug

    Also called Taxotere

    Every 3 weeks

  • PaclitaxelDrug

    Also called Taxol

    Every week

  • EribulinDrug

    Also called Halaven

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

Study groups in NCT03264547
Study groupRoleWhat they receive
Arm AActive comparatorTrastuzumab + pertuzumab + Taxane* *Taxane is chosen from the following; Docetaxel or Paclitaxel
Receives: Drug: Pertuzumab; Drug: Trastuzumab; Drug: Docetaxel; Drug: Paclitaxel
Arm BExperimentalTrastuzumab+ Pertuzumab + Eribulin
Receives: Drug: Pertuzumab; Drug: Trastuzumab; Drug: Eribulin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS

    Progression-free survival

    Measured: 5.75 years

Secondary outcomes (8)

  1. RR

    Response rate

    Measured: 5.75 years

  2. DR

    Duration of response

    Measured: 5.75 years

  3. OS

    Overall survival

    Measured: 6.25 years

  4. PRO

    Patient-reported outcomes(Numbness \& tingling)

    Measured: 5.75 years

  5. Safety

    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

    Measured: 5.75 years

  6. Biomaker

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

    Measured: 5.75 years

  7. nMFS

    new Metastases free survival

    Measured: 5.75 years

  8. TTF of the subsequent treatment

    Treatment duration of the following treatment

    Measured: 5.75 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2017
  2. Study start28 Aug 2017
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
446 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03264547
Sponsor's protocol ID
JBCRG-M06
Status last verified
Sep 2025
First submitted
1 Aug 2017
Last updated
29 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22149875

  • 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.

    PubMed 21376385

  • 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.

    PubMed 25605862

  • 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.

    PubMed 25024001

  • Masuda N, Saji S, Kojima Y, Kitada M, Tada H, Iwasa T, Koizumi K, Iwatani T, Sagara Y, Kuwayama T, Shimoda M, Sasada T, Tsugawa K, Kawaguchi Y, Shimomura A, Yamaguchi T, Hasegawa H, Osaka S, Morita S, Yamashita T. Efficacy and safety of eribulin mesylate vs. docetaxel or paclitaxel, combined with trastuzumab and pertuzumab, as first-line treatment for HER2-positive locally advanced or metastatic breast cancer: updated subgroup analyses of JBCRG-M06/EMERALD. Breast Cancer Res Treat. 2026 Jul 8;218(1):3. doi: 10.1007/s10549-026-08004-5.

    PubMed 42420599

  • 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.

    PubMed 39787453

  • 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.

    PubMed 32381018

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pertuzumab, Trastuzumab and Docetaxel in people with Breast Cancer, run by Japan Breast Cancer Research Group at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: 5.75 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03264547, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.

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