A Study to Evaluate Safety, Tolerability and Efficacy of Eribulin Mesylate in Treating Adult Females With Locally Advanced or Metastatic Breast Cancer
NCT ID: NCT03583944
Last Updated: 2019-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2018-03-28
2019-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Eribulin Mesylate 1.23 mg
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.
Eribulin Mesylate
Eribulin mesylate IV infusion.
Interventions
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Eribulin Mesylate
Eribulin mesylate IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Eisai Inc.
Locations
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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
KR Hospital Mysore Medical College
Mysore, Karnataka, India
Tata Memorial Hospital Department of Oncology
Mumbai, Maharashtra, India
HCG NCHRI Cancer Centre
Nagpur, Maharashtra, India
Lokmanya Hospital
Pune, Maharashtra, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India
All India Institute of Medical Sciences
Bhubaneswar, Odisha, India
Deep Hospital
Ludhiana, Punjab, India
Sawai Man Singh Hospital
Jaipur, Rajasthan, India
MNJ Institute of Oncology and Regional Cancer Centre
Hyderabad, Telangana, India
J.K.Cancer Institute
Kanpur, Uttar Pradesh, India
King George's Medical University,(Erstwhile Chhatrapati Shahuji Maharaj Medical University)
Lucknow, Uttar Pradesh, India
Ajanta Research Centre, Ajanta Hospital & IVF Centre
Lucknow, Uttar Pradesh, India
Nilratan Sircar Medical College and Hospital
Kolkata, West Bengal, India
Netaji Subhash Chandra Bose Cancer Institute
Kolkata, West Bengal, India
IPGME&R S.S.K.M Hospital
Kolkata, West Bengal, India
Countries
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Other Identifiers
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E7389-M065-401
Identifier Type: -
Identifier Source: org_study_id
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