Post Marketing Study of Eribulin Mesylate in Patients with Breast Cancer
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified siteHealth 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
- Registration Number
- CTRI/2018/03/012349
- Lead Sponsor
- Eisai Pharmaceuticals India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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
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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br/ ><br>Timepoint: six Cycles
- Secondary Outcome Measures
Name Time Method 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