Trial record 5 of 285 for:    "Breast cancer male"

Eribulin Mesylate in Treating Patients With Previously Treated Metastatic Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Washington
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01908101
First received: July 19, 2013
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Male Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Drug: eribulin mesylate
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Metronomic Eribulin (Halaven) In Pretreated Metastatic Breast Cancer (MBC)

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • PFS [ Time Frame: From study enrollment until the earliest date of disease progression or death, assessed up to 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Prevalence of key adverse events graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
    Will be calculated and 95% Wilson (score) confidence intervals reported for each.


Estimated Enrollment: 60
Study Start Date: January 2014
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: eribulin mesylate
Given IV
Other Names:
  • B1939
  • E7389
  • ER-086526
  • halichrondrin B analog
Other: laboratory biomarker analysis
Correlative studies

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 at 30 days and for 1 year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 with 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
  • 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 =< 2.5 x ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 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:

  • 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01908101

Locations
United States, Arizona
Arizona Cancer Center - Tucson Not yet recruiting
Tucson, Arizona, United States, 85724-5024
Contact: Pavani Chalasani    520-626-0191      
Principal Investigator: Pavani Chalasani         
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Hannah M. Linden    206-288-1234      
Principal Investigator: Hannah M. Linden         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Hannah Linden Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01908101     History of Changes
Other Study ID Numbers: 8093, NCI-2013-01326, 8093, P30CA015704
Study First Received: July 19, 2013
Last Updated: February 11, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Breast Neoplasms
Breast Neoplasms, Male
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 29, 2014