Eribulin With Trastuzumab as First-line Therapy for Locally Recurrent or Metastatic HER2 Positive Breast Cancer

NCT01269346 | Completed Phase 2 Results

• 1 other identifier: E7389-A001-208
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 26

Brief Summary

This is a multicenter phase 2 study designed to evaluate the safety and efficacy of eribulin mesylate in combination with trastuzumab as first line treatment in female subjects with locally recurrent or metastatic human epidermal growth factor receptor (HER2) positive breast cancer.

Conditions

Breast Cancer

Keywords

Locally recurrent; metastatic HER2Positive breast cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  The Objective Response Rate (Complete Response plus Partial Response, (CR + PR)) was defined as the proportion of participants who have a best overall response of confirmed CR or PR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the Investigator. Tumor assessment was by computed tomography (CT)/magnetic resonance imaging (MRI). To assess best response (CR, PR, stable disease (SD), progressive disease (PD), or not estimable (NE)), the Investigator selected up to five measurable target lesions (2 per organ). All other lesions were identified as nontarget lesions. Each participant's overall tumor burden at Baseline was compared with subsequent measurements of the target lesions. For participants with CR or PR, changes in tumor sizes had to be confirmed by repeat evaluations performed not fewer than four weeks after the initial response assessment.

  Baseline (within 28 days of first infusion of study drug); Treatment Phase (every 6 weeks during the first 6 cycles); Extension Phase (every 12 weeks) to PR or CR

Secondary Outcomes (4)

• Time to First Response

  From date of first dose of study drug to the earliest date that CR or PR was objectively documented, assessed up to data cutoff (12 Sep 2013), up to approximately 2 years 9 months

• Duration of Response (DOR)

  Date of a confirmed CR or PR was first documented to the date of PD or death (due to any cause and in the absence of PD), whichever occurred first, or date of data cutoff (12 Sep 2013), or up to approximately 2 years 9 months

• Progression-Free Survival (PFS)

  Date of first dose of study drug to date of PD or death (from any cause) whichever came first, or date of data cutoff (12 Sep 2013), up to approximately 2 years 9 months

• Duration of Stable Disease (SD)

  Start of study treatment to date of PD or death, whichever occurred first, or date of data cutoff (12 Sep 2013), up to approximately 2 years 9 months

Study Arms (1)

1

EXPERIMENTAL

Drug: Eribulin Mesylate

Interventions

Eribulin Mesylate DRUG

Eribulin mesylate 1.4 mg/m2 administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle. Trastuzumab 8 mg/kg will be administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg will be administered as an IV infusion over a 30-minute period on Day 1 of each subsequent cycle.

1

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• Histologically or cytologically proven adenocarcinoma of the breast
• Subjects who have locally recurrent or metastatic disease with at least one measurable lesion
• HER2 positive as determined by score of 3 on immunohistochemistry (IHC) staining or gene amplification by fluorescence in situ hybridization (FISH).
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0, 1 or 2
• At least 12 months since prior neoadjuvant or adjuvant chemotherapy
• At least 2 weeks since prior radiotherapy, endocrine therapy, trastuzumab, or lapatinib, with complete recovery from the effects of these interventions
• Adequate renal function
• Adequate bone marrow function
• Adequate liver function
• Adequate cardiac function

You may not qualify if:

• Prior chemotherapy, biologic therapy, or investigational therapy for locally recurrent or metastatic HER2 breast cancer.
• Subjects who have had a prior malignancy other than carcinoma in situ of the cervix, or nonmelanoma skin cancer
• Prior exposure to greater than 360 mg/m2 doxorubicin or liposomal doxorubicin, greater than 120 mg/m2 mitoxantrone, greater than 90 mg/m2 idarubicin, or greater than 720 mg/m2 epirubicin
• Inflammatory breast cancer
• Prior history of hypertensive crisis or hypertensive encephalopathy
• Clinically significant cardiovascular impairment
• Subjects with known central nervous system (CNS) disease are not eligible, except for those subjects with treated brain metastasis.
• Subjects with metastatic disease limited to bone are ineligible unless there is at least one lytic lesion with identifiable soft tissue components that can be evaluated by computed tomography (CT) or magnetic resonance imaging (MRI)
• Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring the use of oxygen
• History of bleeding diasthesis
• Currently pregnant or breast-feeding.
• Subjects with preexisting Grade 3 or 4 neuropathy. Any peripheral neuropathy must recover to Grade less than or equal to 2 before enrollment

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (26)

University of Colorado

Denver, Colorado, 80204, United States

Location

Florida Cancer Care

Davie, Florida, 33328, United States

Location

Florida Oncology Associates

Jacksonville, Florida, 32256, United States

Location

Ocala Oncology Center

Ocala, Florida, 34471, United States

Location

Peachtree Hematology Oncology Associates, PC

Atlanta, Georgia, 30309, United States

Location

Northwest Georgia Oncology Centers, P.C.

Marietta, Georgia, 30060, United States

Location

Montgomery Cancer Center

Mount Sterling, Kentucky, 40353, United States

Location

Jackson Oncology Associates, PLLC

Jackson, Mississippi, 39202, United States

Location

Heartland Regional Medical Center

Saint Joseph, Missouri, 64507, United States

Location

Weill Cornell Breast Clinic

New York, New York, 10065, United States

Location

Raleigh Hematology Associates

Raleigh, North Carolina, 27607, United States

Location

Cancer Care of the Cascades

Bend, Oregon, 97701, United States

Location

Medical Oncology Associates of Wyoming Valley, P.C.

Kingston, Pennsylvania, 18704, United States

Location

Charleston Hematology/Oncology

Charleston, South Carolina, 29403, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

C. Michael Jones, MD

Germantown, Tennessee, 38138, United States

Location

Texas Oncology - Beaumont Marnie McFaddin Ward Cancer Center

Beaumont, Texas, 77702-1449, United States

Location

Texas Oncology - Medical City Dallas

Dallas, Texas, 75201, United States

Location

Texas Oncology - El Paso Cancer Treatment Center Grandview

El Paso, Texas, 79902, United States

Location

Texas Oncology - Memorial City

Houston, Texas, 77024, United States

Location

Texas Oncology - McAllen South Second Street

McAllen, Texas, 78503, United States

Location

Cancer Care Centers of South Texas

San Antonio, Texas, 78217, United States

Location

Texas Oncology - Sherman

Sherman, Texas, 75090, United States

Location

Texas Oncology - Sugar Land

Sugar Land, Texas, 77479, United States

Location

Pensisula Cancer Institute

Newport News, Virginia, 23601, United States

Location

Columbia Basin Hematology and Oncology

Kennewick, Washington, 99336, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

eribulin

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Eisai Medical Services
• Organization: Eisai Inc.

esi_medinfo@eisai.com

1-888-422-4743

Study Officials

• Sam Misir

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2010
• First Posted: January 4, 2011
• Study Start: December 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: May 1, 2016
• Last Updated: June 22, 2023
• Results First Posted: March 30, 2017

Record last verified: 2017-02

Locations

US (26)