Health Condition 1: C509- Malignant neoplasm of breast of unspecified site Health Condition 2: null- Patients with locally advanced or metastatic breast cancer, who have progressed after at least one regimens of chemotherapy which has included anthracycline and taxane therapy
Conditions
Interventions
Intervention1: Eribulin 1.23 mg (equivalent to Eribulin mesylate 1.4mg)/m2 IV infusion: Eribulin 1.23 mg (equivalent to Eribulin mesylate 1.4mg)/m2 IV infusion given over 2 – 5 minutes on days 1 and 8
Sponsors
Eisai Pharmaceuticals India Private Limited
Accutest Research Laboratories I PvtLtd
Eligibility
Inclusion 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 Serum AST (SGOT) and ALT (SGPT) Serum Creatinine 8.Women in reproductive age willing to follow adequate barrier contraceptive measures during the conduct of study
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate the clinical and laboratory safety of Eribulin mesylate in treating patients with locally advanced or metastatic breast cancer, who have progressed after at least one regimens of chemotherapy which has included anthracycline and taxane therapy Timepoint: six Cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the objective response rate (ORR) with Eribulin in patients with locally advanced or metastatic breast cancer, who have progressed after at least one regimens of chemotherapy which has included anthracycline and taxane therapyTimepoint: Six Cycles | — |
Countries
India
Contacts
Public ContactSachin D Pawar
Accutest Research Laboratories(I) Pvt Ltd
Outcome results
None listed