Eribulin Mesylate in Treating Patients With Previously Treated Metastatic Breast Cancer

NCT01908101 | Completed Phase 2 Results

• 3 other identifiers: 8093NCI-2013-01326P30CA015704
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 12

Brief Summary

This phase II trial studies how well eribulin mesylate works in treating patients with previously treated breast cancer that has spread to other places in the body. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Conditions

Recurrent Breast Carcinoma; Stage IV Breast Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  Kaplan-Meier survival curves will be used to describe PFS, overall and stratified by number of prior metastatic treatment regimens. A 95% confidence interval for the median PFS will be calculated using the method of Brookmeyer and Crowley.

  From study enrollment until the earliest date of disease progression or death, assessed up to 1 year

Study Arms (1)

Treatment (eribulin mesylate)

EXPERIMENTAL

Patients receive eribulin mesylate IV over 2-5 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Drug: Eribulin Mesylate; Other: Laboratory Biomarker Analysis

Interventions

Eribulin Mesylate DRUG

Given IV

Also known as: B1939 Mesylate, E7389, ER-086526, Halaven, Halichondrin B Analog

Treatment (eribulin mesylate)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (eribulin mesylate)

Eligibility Criteria

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

You may qualify if:

• Ability to provide written informed consent
• Prior exposure to taxane in the adjuvant, neoadjuvant or metastatic setting
• At least one prior regimen of chemotherapy in the setting of metastatic breast cancer; no upper limit on the number of prior endocrine regimens for metastatic breast cancer, however no more than 6 chemotherapeutic regimens may have been given in the metastatic setting
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Patients must have baseline imaging within 30 days prior to the start of therapy and satisfy one of the following:
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
• At least one non lymph node lesion of \>= 1.0 cm or lymph node \>= 1.5 cm in short axis by computerized tomography (CT) scan (CT scan thickness no greater than 5 mm which is serially measurable according to RECIST 1.1 using either computerized tomography (CT) or magnetic resonance imaging (MRI)
• Lesions that have had radiotherapy must show evidence of progressive disease (PD) based on RECIST 1.1 to be deemed a target lesion
• Non-measurable disease by RECIST 1.1 criteria (includes bone only disease and lesions \< 10 mm or lymph nodes \< 15 mm in short axis) with rising serum CA15-3 or CA 27.29 or CEA documented by two consecutive measurements taken at least 14 days apart with the most recent measurement being within 42 days prior to registration. The second CA 15-3 or CA 27.29 value must have at least a 20% increase over the first and for CA 15-3 or CA27.29 be greater than or equal to 40 units/mL or for CEA be greater than or equal to 4 ng/mL
• Absolute neutrophil count \>= 1,500/mm\^3
• Hemoglobin \>= 10 g/dL
• Platelets \>= 100,000/mm\^3
• Creatinine =\< 1.5 x upper limit of normal (ULN)
• Total bilirubin =\< 1.5 x ULN
• Alkaline phosphatase =\< 3.0 x ULN; up to 5 x ULN is acceptable if due to bone metastases in the absence of liver metastases

You may not qualify if:

• Prior treatment with eribulin
• Plan to administer any other systemic antitumor including endocrine therapy except for following standard of care treatment:
• Trastuzumab at standard dosing human epidermal growth factor receptor 2 (HER2) positive tumors
• Denosumab or bisphosphonates to treat metastatic bone disease
• Plan to administer concurrent radiation therapy now or for progressive symptoms during treatment
• Patients with known central nervous system (CNS) metastases must have stable disease off steroids after treatment with surgery or radiation therapy
• Second primary malignancy that is clinically detectable or clinically significant at the time of consideration for study enrollment
• Patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic and/or moderate (creatinine clearance \[CrCl\] 30-50 mL/min) renal impairment
• Radiotherapy within 14 days of study treatment
• Major surgery within 21 days of study treatment; minor surgery within 2 weeks of study treatment; placement of vascular access device and biopsies allowed and is not considered major or minor surgery
• Treatment with any systemic chemotherapy or investigational agents within 3 weeks of the start of study treatment; endocrine treatment must be stopped prior to initiating study treatment; subjects must have recovered from toxicities of prior therapy
• Patients with peripheral neuropathy \> grade 2 regardless of etiology
• Significant cardiovascular impairment: congestive heart failure \> class II according to the New York Heart Association (NYHA), unstable angina or myocardial infarction within 6 months of enrollment, or serious cardiac arrhythmia (\> grade 2)
• Concomitant severe or uncontrolled medical disease
• Significant psychiatric or neurologic disorder which would compromise participation in the study

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (12)

Katmai Oncology Group

Anchorage, Alaska, 99508, United States

Location

Providence Alaska Medical Center

Anchorage, Alaska, 99508, United States

Location

The University of Arizona Medical Center-University Campus

Tucson, Arizona, 85724, United States

Location

Bozeman Deaconess Hospital

Bozeman, Montana, 59715, United States

Location

Bend Memorial Clinic

Bend, Oregon, 97701, United States

Location

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, 99336, United States

Location

Skagit Valley Hospital

Mount Vernon, Washington, 98274, United States

Location

Olympic Medical Center

Port Angeles, Washington, 98362, United States

Location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Group Health Cooperative-Seattle

Seattle, Washington, 98112, United States

Location

MultiCare Tacoma General Hospital

Tacoma, Washington, 98405, United States

Location

Wenatchee Valley Hospital and Clinics

Wenatchee, Washington, 98801, 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: Stefanie Parker
• Organization: Seattle Cancer Care Alliance

parkers@seattlecca.org

206-889-0917

Study Officials

• Hannah Linden

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: July 19, 2013
• First Posted: July 25, 2013
• Study Start: January 8, 2014
• Primary Completion: May 4, 2019
• Study Completion: May 4, 2019
• Last Updated: July 23, 2020
• Results First Posted: July 23, 2020

Record last verified: 2020-05

Locations

US (12)