A Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Participants With Advanced Breast Cancer

NCT00879086 | Completed Phase 2 Results

• 1 other identifier: E7389-G000-209
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 50

Brief Summary

The purpose of this study in patients with advanced breast cancer is to compare the incidence and severity of neuropathy adverse events for the two treatment groups (eribulin versus ixabepilone) using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) grading.

Conditions

Breast Cancer

Keywords

Breast Cancer; Oncology

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Treatment-Emergent Neuropathy Adverse Events (AEs)

  Neuropathy AEs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 and coded according to the current version of the Medical Dictionary for Regulatory Activities (MedDRA). Neuropathy AEs included the broad list of preferred terms (PTs) defined in the Standard MedDRA Query for Neuropathy and the following additional PTs: neuropathy, hyperesthesia, painful response to normal stimuli, pallanesthesia, and allodynia. If the post-baseline maximum CTCAE grade of the combined term "neuropathy" was greater than the baseline maximum CTCAE grade of the combined term, then the event was considered as treatment emergent neuropathy adverse events per CTCAE grade. For a single participant, 1) a neuropathy AE occurring more than once during the study, whether defined with the same or different MedDRA PTs, was counted only once, 2) a neuropathy AE with different CTCAE grades had only the highest grade AE counted.

  From administration of first dose up to approximately 5 years

Secondary Outcomes (10)

• Percentage of Participants With an Incidence of Treatment-emergent Myalgia/Arthralgia

  From administration of first dose up to approximately 5 years

• Change From Baseline in Vibration Perception Threshold (VPT)

  Baseline, Treatment Phase: Cycles 2 to 6 (Day 1); Extension Phase: Cycle 9 Day 1, Cycle 12 Day 1, Cycle 15 Day 1 (Each Cycle length=21 days), End of Treatment, Post-treatment Follow-up, Worst Post-baseline result (Up to approximately 5 years)

• Number of Participants With Shift From Baseline to Worst Post-baseline Participant Neurotoxicity Questionnaire (PNQ) Score for Item 1 (Sensory)

  Baseline up to approximately 5 years

• Number of Participants With Shift From Baseline to Worst Post-baseline Participant Neurotoxicity Questionnaire (PNQ) Score for Item 2 (Motor)

  Baseline up to approximately 5 years

• Number of Participants With Shift From Baseline to Worst Post-baseline Participant Neurotoxicity Questionnaire (PNQ) Composite Score

  Baseline up to approximately 5 years

Study Arms (2)

Eribulin mesylate

ACTIVE COMPARATOR

Drug: Eribulin Mesylate

Ixabepilone

ACTIVE COMPARATOR

Drug: Ixabepilone

Interventions

Eribulin Mesylate DRUG

E7389 (eribulin mesylate) given at a dose of 1.4 mg/m\^2 as a 2 to 5 minute intravenous (IV) bolus on Days 1 and 8 of a 21-day cycle. The Treatment Phase will include six cycles. Patients may enter the Extension Phase for additional cycles following the sixth cycle of treatment.

Also known as: E7389

Eribulin mesylate

Ixabepilone DRUG

Ixabepilone given at a starting dose of 32 or 40 mg/m\^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle. The Treatment Phase will include six cycles. Patients may enter the Extension Phase for additional cycles following the sixth cycle of treatment.

Ixabepilone

Eligibility Criteria

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

You may qualify if:

• \. Female subjects with confirmed locally recurrent or metastatic carcinoma of the breast who have received prior taxane therapy and at least one prior cytotoxic chemotherapy regimen for advanced disease.

You may not qualify if:

• Subjects who have received prior ixabepilone therapy.
• Subjects with prior participation in an eribulin clinical study, even if not assigned to eribulin treatment.
• Subjects with pre-existing neuropathy Grade greater than or equal to 2.
• Subjects with a history of diabetes mellitus Type 1 or 2.
• Subjects with bilateral mastectomy which included bilateral axillary lymph node dissection.
• Subjects with missing digits required for vibration assessment.
• Subjects with any other concurrent diseases or conditions that would be expected to interfere with neuropathy assessments, which may include vitamin deficiency, sequelae of cerebrovascular disease, thyroid insufficiency, lumbar or cervical radiculopathy, or alcoholic or inflammatory neuropathy.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (50)

Northern AZ Hematology and Oncology Associates

Sedona, Arizona, 86336, United States

Location

Healing Hands Oncology and Medical Care

Hawthorne, California, 90250, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Comprehensive Cancer Center

Palm Springs, California, 92262, United States

Location

Comprehensive Cancer Care Specialist of Boca

Boca Raton, Florida, 33428, United States

Location

Robert R. Carroll, MD, PA

Gainesville, Florida, 32605, United States

Location

Hematology Oncology Associates

Lake Worth, Florida, 33461, United States

Location

Medical Specialists of the Palm Beaches

Lake Worth, Florida, 33467, United States

Location

Ocala Oncology Center

Ocala, Florida, 34471, United States

Location

Hematology Oncology Associates of Treasure Coast

Port Saint Lucie, Florida, 34952, United States

Location

Oncology and Hematology Associates of West Broward

Tamarac, Florida, 33321, United States

Location

Hematology Oncology Associates of Illinois

Chicago, Illinois, 60611, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Central Indiana Cancer Centers

Indianapolis, Indiana, 46219, United States

Location

Heartland Oncology Hematology

Council Bluffs, Iowa, 51503, United States

Location

Hematology and Oncology Specialists

Marrero, Louisiana, 70072, United States

Location

Metairie Institute of Comprehensive Health

Metairie, Louisiana, 70006, United States

Location

Hematology and Oncology Specialists

New Orleans, Louisiana, 70115, United States

Location

Maryland Oncology Hematology, PA

Columbia, Maryland, 21044, United States

Location

Washington County Hospital

Hagerstown, Maryland, 21740, United States

Location

Josephine Ford Cancer Center

Brownstown, Michigan, 48183, United States

Location

Henry Ford Medical Center-Fairlane

Dearborn, Michigan, 48126, United States

Location

Henry Ford Health Systems

Detroit, Michigan, 48202, United States

Location

Henry Ford Medical Center Farmington

West Bloomfield, Michigan, 48322, United States

Location

Summit Medical Group

Berkeley Heights, New Jersey, 7922, United States

Location

Joan Knechel Cancer Center

Mount Arlington, New Jersey, 7856, United States

Location

Queens Cancer Center of Queens Hospital

Jamaica, New York, 11432, United States

Location

Saint Vincent's Comprehensive Cancer Center

New York, New York, 10011, United States

Location

Weil Cornell Breast Center

New York, New York, 10065, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Charleston Hematology Oncology Associates PA

Charleston, North Carolina, 29403, United States

Location

Cancer Center of North Carolina

Raleigh, North Carolina, 27607, United States

Location

Northwest Cancer Specialists Rose Quarter

Portland, Oregon, 97227, United States

Location

Northwest Cancer Specialists Hoyt

Portland, Oregon, United States

Location

Northwest Cancer Specialists

Tualatin, Oregon, 97062, United States

Location

Lone Star Oncology

Austin, Texas, 78759, United States

Location

South Texas Institute of Cancer

Corpus Christi, Texas, 78405, United States

Location

Northwest Cancer Center

Corpus Christi, Texas, 78410, United States

Location

Texas Oncology-Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Texas Cancer Center at Medical City

Dallas, Texas, United States

Location

Texas Oncology, PA

Dallas, Texas, United States

Location

Texas Oncology, PA Bedford

Houston, Texas, 76033, United States

Location

Texas Oncology, PA

Houston, Texas, 77024, United States

Location

North Texas Regional Cancer Center

Plano, Texas, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Northern Utah Associates

Ogden, Utah, 84403, United States

Location

Virginia Oncology Associates

Newport News, Virginia, 23606, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Northwest Cancer Specialist Vancouver

Vancouver, Washington, 98684, United States

Location

Northwest Cancer Care Specialists, P.C.

Vancouver, Washington, 98686, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

eribulin; ixabepilone

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

esi_oncmedinfo@eisai.com

888-274-2378

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: April 8, 2009
• First Posted: April 9, 2009
• Study Start: March 31, 2009
• Primary Completion: April 30, 2013
• Study Completion: April 30, 2014
• Last Updated: June 22, 2023
• Results First Posted: December 1, 2021

Record last verified: 2021-10

Locations

US (50)