CTRI/2018/03/012349CompletedPhase 4
Post Marketing Trial (Phase IV) on the Safety, Tolerability And Efficacy of Eribulin Mesylate in Treating Patients with Locally Advanced or Metastatic Breast Cancer
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Pms
Eligibility Criteria
Inclusion Criteria
- •1.Females of 18 years of age or older.
- •2.Patients willing to give informed written consent.
- •3.Patients with locally advanced or metastatic breast cancer.
- •4.Patients 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 patients who are not suitable for these treatments.
- •5.Patients must have documented disease progression within or on 6 months from their last anti-cancer therapy.
- •6.ECOG performance status =2
- •7.Patients must have normal organ and marrow function as defined below:Absolute neutrophil count >1,500/mcl
- •Hemoglobin >10.0 g/dL
- •Platelets >100,000/mcL
- •Serum total bilirubin <1.5 X upper limit of normal (ULN)
- •Serum AST (SGOT) and ALT (SGPT) <3 X ULN or <5 X ULN in the presence of liver metastases
- •Serum Creatinine <1.5 mg/dL
- •8.Women in reproductive age willing to follow adequate barrier contraceptive measures during the conduct of study
Exclusion Criteria
- •1.Pregnant and lactating females
- •2.Hypersensitivity to the active substance or any of the excipients
- •3.Patients 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
- •4.Participants receiving any other investigational agents
Investigators
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