Eribulin Mesylate in Treating Patients With Previously Treated Metastatic Breast Cancer

Stage IV Breast Cancer Clinical Trial

Official title:

Phase II Trial of Metronomic Eribulin (Halaven) in Pretreated Metastatic Breast Cancer (MBC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01908101
• Other study ID #: 8093
• Secondary ID: NCI-2013-0132680
• Status: Completed
• Phase: Phase 2
• Start date: January 8, 2014
• Est. completion date: May 4, 2019

Study information

• Verified date: May 2020
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: May 4, 2019
• Est. primary completion date: May 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Recurrent Breast Carcinoma
• Stage IV Breast Cancer

Intervention

Drug:
• Eribulin Mesylate
Given IV

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Katmai Oncology Group	Anchorage	Alaska
United States	Providence Alaska Medical Center	Anchorage	Alaska
United States	Bend Memorial Clinic	Bend	Oregon
United States	Bozeman Deaconess Hospital	Bozeman	Montana
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	The University of Arizona Medical Center-University Campus	Tucson	Arizona
United States	Wenatchee Valley Hospital and Clinics	Wenatchee	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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