A Study to Evaluate Safety, Tolerability and Efficacy of Eribulin Mesylate in Treating Adult Females With Locally Advanced or Metastatic Breast Cancer

Eisai

Status and phase: Completed; Phase 4

Conditions: Breast Neoplasms

Treatments: Drug: Eribulin Mesylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT03583944

E7389-M065-401

Details and patient eligibility

About

The purpose of this study is to evaluate clinical and laboratory safety of eribulin mesylate in treating participants with locally advanced or metastatic breast cancer, who have progressed after at least one regimen of chemotherapy which has included anthracycline and taxane therapy.

Enrollment: 200 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants with locally advanced or metastatic breast cancer.

2. Participants must have progressed after at least after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an Anthracycline and a Taxane unless participants who are not suitable for these treatments.

3. Participants must have documented disease progression within or on 6 months from their last anti-cancer therapy.

4. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 2.

5. Participants must have normal organ and marrow function as defined below:

   • Absolute neutrophil count greater than (>) 1,500 per microliter (/mcL)
   • Hemoglobin >10.0 gram per deciliter (g/dL)
   • Platelets >100,000/mcl
   • Serum total bilirubin less than (<) 1.5*upper limit of normal (ULN)
   • Serum aspartate aminotransferase (AST) (Serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (Serum glutamic pyruvic transaminase [SGPT]) <3*ULN or <5*ULN in the presence of liver metastases
   • Serum creatinine <1.5 mg/dL.

6. Females in reproductive age willing to follow adequate barrier contraceptive measures during the conduct of study.

Exclusion criteria

1. Hypersensitivity to the active substance or any of the excipients.
2. Participants who have received chemotherapy, radiation, or biological therapy within two weeks, or hormonal therapy within one week before study treatment start, or any investigational drug within four weeks before study treatment start.
3. Participants receiving any other investigational agents.
4. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, or other comorbid condition that investigator believes may compromise participant's condition.
5. Participants requiring concurrent anti-cancer therapy during the study period.
6. Participants with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting study treatment.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Eribulin Mesylate 1.23 mg

Experimental group

Description:

Participants will receive eribulin mesylate 1.23 mg intravenous (IV) infusion, given over 2 - 5 minutes on Days 1 and 8 of 21 days cycle for a total of 6 cycles.

Treatment:

Drug: Eribulin Mesylate