Advanced and/or metastatic breast cancer MedDRA version: 12.1 Level: LLT Classification code 10006198 Term: Breast cancer recurrent MedDRA version: 12.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer
Conditions
Interventions
Product Name: Eribulin mesylate
Product Code: E7389
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Eribulin mesylate
CAS Number: 253128-41-5
Current Sponsor code: E7389
Concentration
Sponsors
Eisai Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Have recurrent, locally advanced or metastatic breast cancer that has progressed on or after the last anti-cancer therapy • Had prior treatment with, ineligibility for, or commercial unavailability of each of the following therapies: o Anthracyclines, taxanes, and capecitabine o Ixabepilone, in countries where this agent is marketed o Trastuzumab, for Her-2 positive disease o Hormonal therapy, in hormone receptor-positive disease o All other commercially available therapies, e.g. gemcitabine or vinorelbine, used for the treatment of advanced breast cancer (See NCCN guidelines) • Have an ECOG performance status = 2 • Have a serum creatinine = 2.0 mg/dL or creatinine clearance = 40 mL/min according to Cockcroft and Gault formula • Have an absolute neutrophil count = 1.5 x 109/L, hemoglobin = 10 g/dL (can be corrected by growth factor or transfusion), and platelet count = 100 x 109/L • Have a total bilirubin = 1.5 x upper limit of normal (ULN). Alkaline phosphatase, alanine aminotransferase, and aspartate aminotransferase = 3 x ULN (= 5 x ULN in case of liver metastases). In case alkaline phosphatase is > 3 x ULN (in absence of liver metastases) or > 5 x ULN (in presence of liver metastases) AND patient also is known to have bone metastases, the liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase • Are willing and able to comply with all aspects of the treatment protocol • Provide written informed consent. • Are females, age = 18 years • Female subjects of childbearing potential must agree to be abstinent or to use a highly effective method of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, intra-uterine device, or have a vasectomized partner) having started for at least one menstrual cycle prior to starting eribulin and throughout the entire treatment period and for 30 days (longer if appropriate) after the last dose of eribulin. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Are eligible for any other eribulin study that is open in the same region • Have existing anti-cancer therapy-related toxicities of grade = 2, except that alopecia and grade 2 neuropathy are acceptable • Have a history of congestive heart failure with New York Heart Association Classification > II, unstable angina, myocardial infarction within the past 6 months, serious cardiac arrhythmia • Have an electrocardiogram with QTc interval = 500 msec based upon Bazett’s formula (QTcB) • The Investigator believes the subject to be medically unfit to receive eribulin or unsuitable for any other reason • Are females who are pregnant (positive ß-hCG test) or breastfeeding • Are hypersensitive to eribulin or any of the excipients • Have brain or subdural metastases, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this treatment protocol. Any signs (eg, radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks before starting the treatment protocol • Have a history of or concomitant medical condition that, in the opinion of the Investigator, would compromise the subject’s ability to safely complete the treatment protocol • Are known to be human immunodeficiency virus positive because the neutropenia caused by the eribulin treatment may make such subjects particularly susceptible to infection. • Have meningeal carcinomatosis • Have pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen • Have received any of the following treatments within the specified period before the start of treatment: o Any investigational drug within 4 weeks o Chemotherapy, radiation, or biological or targeted therapy within 2 weeks o Hormonal therapy within 1 week.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To provide eribulin to patients with advanced breast cancer who have no further treatment options and therapy is requested by an investigator;Secondary Objective: To further evaluate the safety profile of eribulin.;Primary end point(s): Not applicable | — |
Countries
Belgium
Outcome results
None listed