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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03264547
• Other study ID #: JBCRG-M06
• Status: Recruiting
• Phase: Phase 3
• First received: August 1, 2017
• Last updated: September 19, 2017
• Start date: August 28, 2017
• Est. completion date: October 31, 2023

Study information

• Verified date: September 2017
• Source: Japan Breast Cancer Research Group
• Contact: Toshinari Tamashita, MD, PhD
• Phone: +81-45-520-2222
• Email: tyamashita[@]kcch.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: October 31, 2023
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Pertuzumab
Every 3 weeks
• Trastuzumab
Every 3 weeks
• Docetaxel
Every 3 weeks
• Paclitaxel
Every week
• Eribulin
Administered for 2 weeks and is then stopped to be administered for 1 week

Locations

Country	Name	City	State
Japan	National Hospital Organization Osaka National Hospital	Osaka	Osaka
Japan	Kanagawa Cancer Center	Yokohama	Kanagawa

Sponsors (2)

Lead Sponsor	Collaborator
Japan Breast Cancer Research Group	Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

References & Publications (4)

Baselga J, Cortés 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 1 — View Citation

Cortes J, O'Shaughnessy J, Loesch D, Blum JL, Vahdat LT, Petrakova K, Chollet P, Manikas A, Diéras 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 C — View Citation

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 tre — View Citation

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. Cli — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Progression-free survival	5.75 years
Secondary	RR	Response rate	5.75 years
Secondary	DR	Duration of response	5.75 years
Secondary	OS	Overall survival	6.25 years
Secondary	PRO	Patient-reported outcomes(Numbness & tingling)	5.75 years
Secondary	Safety	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	5.75 years
Secondary	Biomaker	DNA mutation in the ctDNA and tumor tissue such as HER2,HER3, and PIK3CA	5.75 years
Secondary	nMFS	new Metastases free survival	5.75 years
Secondary	TTF of the subsequent treatment	Treatment duration of the following treatment	5.75 years