Clinical trial · Interventional
A Study to Compare Eribulin Mesylate + Pertuzumab + Trastuzumab With Paclitaxel or Docetaxel + Pertuzumab + Trastuzumab
A Phase III Clinical Study to Compare the Combination Therapy of Eribulin Mesylate + Pertuzumab + Trastuzumab With Paclitaxel or Docetaxel + Pertuzumab + Trastuzumab (EMERALD)
NCT03264547CI-TRIAL-00095903completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Eribulin | Drug | Eribulin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pertuzumab | Drug | Pertuzumab | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A
- description
- Trastuzumab + pertuzumab + Taxane\* \*Taxane is chosen from the following; Docetaxel or Paclitaxel
- interventionNames
- Drug: Pertuzumab
- Drug: Trastuzumab
- Drug: Docetaxel
- Drug: Paclitaxel
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Trastuzumab+ Pertuzumab + Eribulin
- interventionNames
- Drug: Pertuzumab
- Drug: Trastuzumab
- Drug: Eribulin
Primary outcomes (1)
- measure
- PFS
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (7)
- RESULTBaselga 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
- RESULTCortes 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
- RESULTKaufman 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
- RESULTWilks 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
- DERIVEDMasuda 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.