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

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ClinicalTrials.gov Identifier: NCT03264547
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : September 21, 2017
Sponsor:
Collaborator:
Eisai Co., Ltd.
Information provided by (Responsible Party):
Japan Breast Cancer Research Group

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

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Pertuzumab Drug: Trastuzumab Drug: Docetaxel Drug: Paclitaxel Drug: Eribulin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Clinical Study to Compare the Combination Therapy of Eribulin Mesylate + Pertuzumab + Trastuzumab With Paclitaxel or Docetaxel + Pertuzumab + Trastuzumab (EMERALD)
Actual Study Start Date : August 28, 2017
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine


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 Name: Perjeta

Drug: Trastuzumab
Every 3 weeks
Other Name: Herceptin

Drug: Docetaxel
Every 3 weeks
Other Name: Taxotere

Drug: Paclitaxel
Every week
Other Name: Taxol

Experimental: Arm B
Trastuzumab+ Pertuzumab + Eribulin
Drug: Pertuzumab
Every 3 weeks
Other Name: Perjeta

Drug: Trastuzumab
Every 3 weeks
Other Name: Herceptin

Drug: Eribulin
Administered for 2 weeks and is then stopped to be administered for 1 week
Other Name: Halaven




Primary Outcome Measures :
  1. PFS [ Time Frame: 5.75 years ]
    Progression-free survival


Secondary Outcome Measures :
  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 Treatment-Emergent Adverse Events [Safety and Tolerability]

  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



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03264547


Contacts
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Contact: Toshinari Tamashita, MD, PhD +81-45-520-2222 tyamashita@kcch.jp

Locations
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Japan
Kanagawa Cancer Center Not yet recruiting
Yokohama, Kanagawa, Japan, 241-8515
Contact: Toshinari Yamashita, MD,PhD    +81-45-520-2222    tyamashita@kcch.jp   
National Hospital Organization Osaka National Hospital Recruiting
Ōsaka, Osaka, Japan, 540-0006
Contact: Norikazu Masuda, MD,PhD    +81-6-6942-1331    nmasuda@alpha.ocn.ne.jp   
Sponsors and Collaborators
Japan Breast Cancer Research Group
Eisai Co., Ltd.
Investigators
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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 of Results:

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Responsible Party: Japan Breast Cancer Research Group
ClinicalTrials.gov Identifier: NCT03264547     History of Changes
Other Study ID Numbers: JBCRG-M06
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pertuzumab
Paclitaxel
Docetaxel
Albumin-Bound Paclitaxel
Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological