Clinical trial NCT03583944: A Study to Evaluate Safety, Tolerability and Efficacy of Eribulin Mesylate in Treating Adult Females With Locally Advanced or Metastatic Breast Cancer
Official title: Post Marketing Trial (Phase IV) on the Safety, Tolerability And Efficacy of Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Neoplasms
Keywords: E7389
Tumors, Breast
Breast Cancer
Breast Carcinoma
Neoplasms, Breast
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-12
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 30 days after last dose of study drug or at discontinuation (approximately up to 17 months)
measure: Number of Participants with TEAEs Related to Laboratory Parameters
timeFrame: Baseline up to 30 days after last dose of study drug or at discontinuation (approximately up to 17 months)
Secondary outcomes:
measure: Objective Tumor Response
timeFrame: Baseline to first date of documented CR, PR, SD, or PD, up to end of study treatment (approximately up to 17 months)
measure: Objective Response Rate (ORR)
timeFrame: Baseline to first date of documented CR, PR, SD, or PD, up to end of study treatment (approximately up to 17 months)
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
city: Ahmedabad
country: India
facility: HEMATO-ONCOLOGY CLINIC Vedanta Institute of Medical Sciences
state: Gujarat
city: Bangalore
country: India
facility: HealthCare Global Enterprises Ltd
state: Karnataka
city: Bangalore
country: India
facility: Srinivasam Cancer Care Multispecialty Hospitals India Pvt Ltd
state: Karnataka
city: Mysore
country: India
facility: KR Hospital Mysore Medical College
state: Karnataka
city: Mumbai
country: India
facility: Tata Memorial Hospital Department of Oncology
state: Maharashtra
city: Nagpur
country: India
facility: HCG NCHRI Cancer Centre
state: Maharashtra
city: Pune
country: India
facility: Lokmanya Hospital
state: Maharashtra
city: Bhubaneswar
country: India
facility: All India Institute of Medical Sciences
state: Orissa
city: Ludhiana
country: India
facility: Deep Hospital
state: Punjab
city: Jaipur
country: India
facility: Sawai Man Singh Hospital
state: Rajasthan
city: Hyderabad
country: India
facility: MNJ Institute of Oncology and Regional Cancer Centre
state: Telangana
city: Kanpur
country: India
facility: J.K.Cancer Institute
state: Uttar Pradesh
city: Lucknow
country: India
facility: King George's Medical University,(Erstwhile Chhatrapati Shahuji Maharaj Medical University)
state: Uttar Pradesh
city: Lucknow
country: India
facility: Ajanta Research Centre, Ajanta Hospital & IVF Centre
state: Uttar Pradesh
city: Kolkata
country: India
facility: Nilratan Sircar Medical College and Hospital
state: West Bengal
city: Kolkata
country: India
facility: Netaji Subhash Chandra Bose Cancer Institute
state: West Bengal
city: Kolkata
country: India
facility: IPGME&R S.S.K.M Hospital
state: West Bengal
Study officials:
affiliation: Eisai Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: