Eribulin Mesylate in Treating Patients With Previously Treated Metastatic Breast Cancer

NCT ID: NCT01908101

Last Updated: 2020-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-08
• Study Completion Date: 2019-05-04

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.

Detailed Description

PRIMARY OBJECTIVES:

I. Progression free survival (PFS).

SECONDARY OBJECTIVES:

I. Frequency of alopecia with absence or decrease to < 50%.

II. Incidence of grade 3 and 4 neutropenia of < 30%.

III. Incidence of sensory neuropathy (all grades) to < 25%.

TERTIARY OBJECTIVES:

I. Assess the role of circulating endothelial cell precursors (CEPs) and apoptotic circulating endothelial cells (CECs), in predicting early response to treatment.

OUTLINE:

Patients receive eribulin mesylate intravenously (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.

After completion of study treatment, patients are followed up for 1 year.

Conditions

Recurrent Breast Carcinoma; Stage IV Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (eribulin mesylate)

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.

Group Type: EXPERIMENTAL

Eribulin Mesylate

Intervention Type: DRUG

Given IV

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Interventions

Eribulin Mesylate

Given IV

Intervention Type: DRUG

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

B1939 Mesylate; E7389; ER-086526; Halaven; Halichondrin B Analog

Eligibility Criteria

Inclusion Criteria

• 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
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x institutional upper limit of normal, unless due to liver metastases (=< 5 x ULN)
• Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation
• Life expectancy of > 12 weeks

Exclusion Criteria

• 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
• Pregnant or breast-feeding females

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hannah Linden

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Katmai Oncology Group

Anchorage, Alaska, United States

Providence Alaska Medical Center

Anchorage, Alaska, United States

The University of Arizona Medical Center-University Campus

Tucson, Arizona, United States

Bozeman Deaconess Hospital

Bozeman, Montana, United States

Bend Memorial Clinic

Bend, Oregon, United States

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, United States

Skagit Valley Hospital

Mount Vernon, Washington, United States

Olympic Medical Center

Port Angeles, Washington, United States

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Group Health Cooperative-Seattle

Seattle, Washington, United States

MultiCare Tacoma General Hospital

Tacoma, Washington, United States

Wenatchee Valley Hospital and Clinics

Wenatchee, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCI-2013-01326

Identifier Type: REGISTRY

Identifier Source: secondary_id

8093

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

8093

Identifier Type: -

Identifier Source: org_study_id