Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment eribulin mesylate
Phase phase 2
Sponsor Eisai Inc.
Start date June 2015
End date November 2016
Trial size 58 participants
Trial identifier NCT02481050, E7389-M001-216

Summary

This is a Phase 2, open-label, single arm, multicenter, 2-stage study of eribulin mesylate administered biweekly at 1.4 mg/m2 intravenously for the treatment of participants with HER2-negative metastatic breast cancer previously treated with 2 to 5 chemotherapy regimens.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants with metastatic HER2-negative breast cancer previously treated with 2 to 5 chemotherapy regimens.
eribulin mesylate Halaven, E7389
Eribulin Mesylate will be administered as a 1.4 mg/m2 intravenous (IV) injection over 2 to 5 minutes biweekly on Day 1 and Day 15 of each 28-day cycle.

Primary Outcomes

Measure
Objective Response Rate (ORR)
time frame: Up to approximately 5 months
Disease Control Rate (DCR)
time frame: Up to approximately 5 months

Secondary Outcomes

Measure
Progression-Free Survival (PFS)
time frame: From date of first dose of study drug administration to date of first documentation of disease progression or death, whichever occurs first or up to approximately 3 years
Overall Survival (OS)
time frame: From date of first dose of study drug administration until date of death from any cause or up to approximately 3 years
Feasibility Rate
time frame: Up to approximately 4 months
Number of participants with treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (SAEs)
time frame: From the time the participant signs the informed consent form until 28 days after last dose of study drug or up to approximately 3 years

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: 1. Histological or cytological adenocarcinoma of the breast 2. Females, aged greater than or equal to 18 years at time of informed consent 3. HER2-negative as determined by fluorescence in situ hybridization (FISH); or 0 or 1+ by immunohistochemistry (IHC) staining 4. Participants with metastatic breast cancer who have received at least 2 and not more than 5 prior chemotherapy regimens 5. Participants with at least one measurable lesion greater than or equal to 10 mm in the longest diameter for a non-lymph node or greater than or equal to 15 mm in the short-axis diameter for a lymph node as determined by investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) 6. Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2 7. Life expectancy of greater than or equal to 3 months 8. Any neuropathy must recover to Grade less than or equal to 2 prior to enrollment 9. Adequate renal function as evidenced by serum creatinine less than or equal to 1.5 mg/dL or calculated creatinine clearance greater than or equal to 50 mL/minute according to the Cockcroft and Gault formula 10. Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) greater than or equal to 1.5 X 10^9/L, hemoglobin greater than or equal to 10.0 g/dL (can be corrected by growth factor or transfusion), and platelet count greater than or equal to 100 X 10^9/L 11. Adequate liver function as evidenced by total bilirubin less than or equal to 1.5 X upper limit of normal (ULN), alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 X ULN (less than or equal to 5 X ULN in the case of liver metastases), unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase 12. Are willing and able to comply with all aspects of the treatment protocol 13. Provide written informed consent Exclusion Criteria: 1. Previous treatment with eribulin 2. Hypersensitivity to eribulin/excipients or halichondrin B or known intolerance of eribulin 3. Current enrollment in another clinical study or used of any investigational drug or device within the past 28 days preceding informed consent 4. Previous treatment with chemotherapy, radiation, biological, or targeted therapy within the last 2 weeks or 5 X half-life, whichever is longer, preceding informed consent 5. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin ([B-hCG] test). A separate Baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug. 6. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing) 7. Females of childbearing potential who had unprotected sexual intercourse within 30 days before study entry and who do not agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for 28 days after study drug discontinuation. Females who are currently abstinent and do not agree to use a double barrier method as described above or to refrain from sexual activity during the study period or for 28 days after study drug discontinuation. Females who are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive during the study or for 28 days after study drug discontinuation. 8. Known central nervous system (CNS) disease, except for those participants with treated brain metastasis who are stable for at least 1 month with no evidence of progression or hemorrhage after treatment and no ongoing requirement for corticosteroids 9. Known human immunodeficiency virus (HIV) positive 10. Existing anticancer, therapy-related toxicities of Grades greater than or equal to 2, with the exception of alopecia 11. A prior malignancy other than carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated greater than 5 years previously with no subsequent evidence of recurrence 12. Clinically significant cardiovascular impairment (congestive heart failure of New York Heart Association [NYHA] Classification greater than II, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia) 13. Clinically significant ECG abnormality, including a marked Baseline prolonged QT/QTc interval (ie, a repeated demonstration of a QTc interval greater than 500 milliseconds) 14. Pulmonary lymphangitic involvement that resulted in pulmonary dysfunction requiring active treatment, including the use of oxygen 15. History of concomitant medical condition(s) that, in the opinion of the investigator, would compromise the participant's ability to safely complete the study 16. The investigator's belief that the participant is medically unfit to receive eribulin or unsuitable for any other reason

Additional Information

Official title To Evaluate the Efficacy and Safety of Eribulin Mesylate Administered Biweekly for Subjects With HER2 Negative Metastatic Breast Cancer
Description This is a Phase 2, open-label, single arm, multicenter, 2-stage study of eribulin mesylate administered biweekly at 1.4 mg/m2 intravenously for the treatment of participants with HER2-negative metastatic breast cancer previously treated with 2 to 5 chemotherapy regimens. The study will be conducted in 3 Phases: a Pretreatment Phase (screening visit), a Treatment Phase (starting with Cycle 1 Day 1), and a Posttreatment Phase (End of treatment visit and survival follow up). Participants may remain on study drug as long as they demonstrate clinical benefit or until intercurrent illness, unacceptable toxicity, or disease progression occurs, until the participant withdraws consent, or death.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Eisai Inc..