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

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03583944
• Other study ID #: E7389-M065-401
• Status: Completed
• Phase: Phase 4
• Start date: March 28, 2018
• Est. completion date: June 28, 2019

Study information

• Verified date: July 2018
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 28, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Eribulin Mesylate
Eribulin mesylate IV infusion.

Locations

Country	Name	City	State
India	HEMATO-ONCOLOGY CLINIC Vedanta Institute of Medical Sciences	Ahmedabad	Gujarat
India	HealthCare Global Enterprises Ltd	Bangalore	Karnataka
India	Srinivasam Cancer Care Multispecialty Hospitals India Pvt Ltd	Bangalore	Karnataka
India	All India Institute of Medical Sciences	Bhubaneswar	Orissa
India	MNJ Institute of Oncology and Regional Cancer Centre	Hyderabad	Telangana
India	Sawai Man Singh Hospital	Jaipur	Rajasthan
India	J.K.Cancer Institute	Kanpur	Uttar Pradesh
India	IPGME&R S.S.K.M Hospital	Kolkata	West Bengal
India	Netaji Subhash Chandra Bose Cancer Institute	Kolkata	West Bengal
India	Nilratan Sircar Medical College and Hospital	Kolkata	West Bengal
India	Ajanta Research Centre, Ajanta Hospital & IVF Centre	Lucknow	Uttar Pradesh
India	King George's Medical University,(Erstwhile Chhatrapati Shahuji Maharaj Medical University)	Lucknow	Uttar Pradesh
India	Deep Hospital	Ludhiana	Punjab
India	Tata Memorial Hospital Department of Oncology	Mumbai	Maharashtra
India	KR Hospital Mysore Medical College	Mysore	Karnataka
India	HCG NCHRI Cancer Centre	Nagpur	Maharashtra
India	Sir Ganga Ram Hospital	New Delhi	Delhi
India	Lokmanya Hospital	Pune	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Clinical Safety will be assessed by recording the adverse events (AEs) and serious AEs (SAEs) observed during the study period and its relation to the study medication. AE is defined as any untoward medical occurrence in a participant administered a treatment of medicinal product. An SAE is any untoward medical occurrence that at any dose results in death, results in life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or results in a congenital anomaly/birth defect.	Baseline up to 30 days after last dose of study drug or at discontinuation (approximately up to 17 months)
Primary	Number of Participants with TEAEs Related to Laboratory Parameters	AE is defined as any untoward medical occurrence in a participant administered a treatment of medicinal product. An SAE is any untoward medical occurrence that at any dose results in death, results in life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or results in a congenital anomaly/birth defect. TEAEs are defined as those events that started on or after the date and time of administration of the first dose of study drug and those events that were present prior to the administration of the first dose of study drug and increased in severity during the study.	Baseline up to 30 days after last dose of study drug or at discontinuation (approximately up to 17 months)
Secondary	Objective Tumor Response	Radiological confirmation of objective response rate (ORR) will be assessed by the Response Evaluation Criteria in Solid Tumors(RECIST)criteria version 1.1. The response would be assessed based on the four response parameters -complete response(CR), partial response(PR), stable disease(SD), progressive disease(PD).CR is defined as disappearance of all target lesions. PR is seen when there is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameters. When there is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of longest diameters since the treatment started then, the response is evaluated as SD.PD is seen when there is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions.	Baseline to first date of documented CR, PR, SD, or PD, up to end of study treatment (approximately up to 17 months)
Secondary	Objective Response Rate (ORR)	ORR measures the response rate using the formula - CR+PR/ (number of eligible participants)*100. CR is defined as disappearance of all target lesions. PR is seen when there is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameters.	Baseline to first date of documented CR, PR, SD, or PD, up to end of study treatment (approximately up to 17 months)