Clinical Trials /

Study to Evaluate the Efficacy and Safety of Eribulin Mesylate Administered Biweekly (Q2W) for Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic Breast Cancer

NCT02481050

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study to Evaluate the Efficacy and Safety of Eribulin Mesylate Administered Biweekly (Q2W) for Subjects With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic Breast Cancer
  • Official Title: To Evaluate the Efficacy and Safety of Eribulin Mesylate Administered Biweekly for Subjects With HER2 Negative Metastatic Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: E7389-M001-216
  • NCT ID: NCT02481050

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
Eribulin MesylateHalaven, E7389Eribulin Mesylate

Purpose

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.

Detailed 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 Arms

NameTypeDescriptionInterventions
Eribulin MesylateExperimentalParticipants with metastatic HER2-negative breast cancer previously treated with 2 to 5 chemotherapy regimens.
  • Eribulin Mesylate

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:Up to approximately 5 months
Safety Issue:
Description:

Secondary Outcome Measures

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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Feasibility Rate
Time Frame:Up to approximately 4 months
Safety Issue:
Description:Feasibility rate is defined as the percentage of participants completing the first 2 and 4 cycles (1 cycle = 28 days) of eribulin treatment (4 and 8 doses) without requiring dose delay greater than 5 days or reduction due to AE.
Measure: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
Safety Issue:
Description:Safety will be assessed by monitoring and recording all AEs and SAEs, regular monitoring of hematology and clinical chemistry, urinalysis, regular measurement of vital signs, 12-lead electrocardiograms (ECGs), and performance of physical examinations.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Eisai Inc.

Trial Keywords

  • Eribulin Mesylate
  • Human Epidermal Growth Factor Receptor 2
  • Metastatic Breast Cancer
  • HER2-Negative

Last Updated

January 2, 2018