Eribulin Mesylate Phase IV Clinical Trial in Korean Patients With Metastatic or Locally Advanced Breast Cancer (ESKIMO)

• ClinicalTrials.gov Identifier: NCT01961544
• Recruitment Status: Completed
• First Posted: October 11, 2013
• Results First Posted: October 7, 2016
• Last Update Posted: October 7, 2016
• Sponsor: Eisai Korea Inc.
• Information provided by (Responsible Party): Eisai Inc. ( Eisai Korea Inc. )

Study Description

Brief Summary:

This clinical study is designed as an open, single group, multi-center, phase 4 clinical study to assess the safety of eribulin which is approved for the treatment of the patients in Korea with locally advanced or metastatic breast cancer who had received two to five prior chemotherapy regimens including anthracyclines and taxanes for advanced disease.

Subjects who meet the inclusion/exclusion criteria are administered of 1.4 mg/m2 of the investigational product intravenously in 2-5 min on day 1 and day 8 of every 21-day cycle. In case of the progression of disease, unacceptable toxicity, withdrawal of the consent, or judgment by investigator that the treatment needs to be stopped, the treatment of investigational product is stopped, and treatment termination assessment is performed within 30 days from the last treatment.

Condition or disease	Intervention/treatment	Phase
Breast Neoplasms; Breast Cancer	Drug: Eribulin mesylate	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 101 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase IV Clinical Trial to Evaluate Safety of Eribulin in Patients With Locally Advanced or Metastatic Breast Cancer
• Study Start Date: June 2013
• Actual Primary Completion Date: July 2015
• Actual Study Completion Date: July 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Eribulin mesylate; 1.4 mg/m2 (as eribulin 1.23 mg/m2) day by 2-5 minutes IV on Day 1 and 8 every 21 days	Drug: Eribulin mesylate; 1.4 mg/m2 (as eribulin 1.23 mg/m2) day by 2-5 minutes IV on Day 1 and 8 every 21 days

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-emergent Serious Adverse Event (SAE) [ Time Frame: mean of 3.76 months ]
   An AE is defined as any harmful, untoward sign (including abnormal laboratory value, etc.), symptom, or disease in a participant administered investigational product that does not necessarily have a causal relationship with treatment. An SAE is defined as an AE that is life threatening or results in death, results in hospitalization (initial or prolonged), results in a disability (significant, persistent, or permanent change, impairment, damage or disruption in the participant's body function/structure, physical activities, or quality of life), results in a congenital anomaly, or requires intervention to prevent permanent impairment or damage. TEAEs are defined as those events that started on or after the date and time of administration of the first dose of study drug and those events that were present prior to the administration of the first dose of study drug and increased in severity during the study.

Secondary Outcome Measures :

1. Disease Control Rate (DCR) [ Time Frame: mean of 3.76 months ]
   DCR is defined as the number of participants with complete response (CR), partial response (PR), and stable disease (SD). The Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was used to assess the tumor response. Tumor response was evaluated by investigators. CR is defined as the disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to <10 millimeters (mm) in the short axis. PR is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]. The SLD must also demonstrate an absolute increase of at least 5 mm. [Two lesions increasing from 2 mm to 3 mm, for example, does not qualify]).

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Female, Age greater or equal to 20 years
2. Patients with histologically or cytologically confirmed carcinoma of the breast
3. Patients with locally advance or metastatic carcinoma of the breast
4. Patients who have received two to five prior chemotherapeutic regimens including an antracycline and a taxane and 2 or more regimens for locally recurrent and/or metastatic disease
5. Patients must have proved refractory to the most recent chemotherapy on or within six (6) months of therapy
6. Patients who have assessable lesion according to RECIST v 1.1

7. Adequately maintained bone marrow function

   • 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 (a hemoglobin less than 10.0 g/dL is acceptable if it is corrected by erythropoietin or transfusion)
   • Platelet count greater than or equal to 100 x 10^9 /L

8. Adequately maintained liver function

   • Total bilirubin: less than or equal to 1.5 times the upper limits of normal (ULN) and
   • Alkaline phosphatase(ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 x ULN (in the case of liver metastases less than or equal to 5 x ULN)

9. Adequately maintained renal function

   • Serum creatinine less than or equal to 2.0 mg/dl or
   • Calculated creatinine clearance greater than or equal to 40 ml/min (Cockcroft and Gault formula)

10. Resolution of all chemotherapy or radiation-related toxicities to Grade 1 severity or lower, except for

    • alopecia
    • stable sensory neuropathy less than or equal to Grade 2
11. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
12. Life expectancy of greater than or equal to 3 months
13. Patients willing and able to comply with the study protocol for the duration of the study
14. Patients who have provided written consent to participate in this study

Exclusion Criteria

1. Patients who have received a chemotherapy, radiation, biologics, immunotherapy or hormonal therapy within three weeks before treatment start (but, palliative radiation can be enrolled)
2. Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen
3. Patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least four weeks before starting treatment in this study. Any signs and/or symptoms of brain metastases must be stable for at least four weeks before starting study treatment
4. Patients with meningeal carcinomatosis

5. Significant cardiovascular impairment

   • Myocardial infarction within the past six months, unstable angina, history of congestive heart failure NYHA class III or IV, or serious cardiac arrhythmia
   • QTc prolongation (Bazett's Formula greater than 480 msec) or congenital long QT syndrome
6. Severe/uncontrolled intercurrent illness/infection required administration of antibiotic injection
7. Patients who have processed a major surgery within four weeks before participation in this clinical trial
8. Patients who have had a prior malignancy within the past five years other than breast cancer (but, treated non-melanoma skin cancer and carcinoma in situ of the cervix will not be excluded)
9. Patients with known positive HIV status
10. Patients who have received genetic therapy or other investigational drug within 4 weeks before treatment start or expected to receive prohibited medication
11. Patients with prior allergies to Halichondrin B, its derivatives, active ingredient, or other diluting agent
12. Patients who have received this investigational product before registration for this study
13. Patients who are pregnant, who may possibly be pregnant, or are lactating
14. Patients who do not agree to practice contraception for the study periods
15. Patients who have participated in other clinical trial within 4 weeks before screening
16. Patients otherwise judged by investigator or sub investigator to be unsuitable for inclusion

Contacts and Locations

Locations

Korea, Republic of

Chungbuk National University Hospital

Cheongju, Chungcheongbuk-do, Korea, Republic of, 361-711

National Cancer Center

Goyang, Gyeonggi-do, Korea, Republic of, 410-769

Seoul National University Bundang Hospital

Seongnam, Gyeonggi-do, Korea, Republic of, 463-707

Ajou University Hospital

Suwon, Gyeonggi-do, Korea, Republic of, 443-380

Dong-A University Hospital

Busan, Korea, Republic of, 602-715

Kyungpook National University Hospital

Daegu, Korea, Republic of, 700-721

Gachon University Gil Medical Center

Incheon, Korea, Republic of, 405-760

Seoul National University Hospital

Seoul, Korea, Republic of, 110-744

Severance Hospital

Seoul, Korea, Republic of, 120-752

Samsung Medical Center

Seoul, Korea, Republic of, 135-710

Korea University Anam Hospital

Seoul, Korea, Republic of, 136-705

Asan Medical Center

Seoul, Korea, Republic of, 138-736

Korea University Guro Hospital

Seoul, Korea, Republic of, 152-703

Ulsan University Hospital

Ulsan, Korea, Republic of, 682-714

Sponsors and Collaborators

Eisai Korea Inc.

More Information

• Responsible Party: Eisai Korea Inc.
• ClinicalTrials.gov Identifier: NCT01961544
• Other Study ID Numbers: EKI-CT-1301
• First Posted: October 11, 2013
• Results First Posted: October 7, 2016
• Last Update Posted: October 7, 2016
• Last Verified: August 2016

Keywords provided by Eisai Inc. ( Eisai Korea Inc. ):

Breast Cancer; Metastatic

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases