Phase II Extension Study of E7389 for Locally Advanced or Metastatic Breast Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Eisai Co., Ltd.
- Enrollment
- 81
- Primary Endpoint
- Number of Subjects With Adverse Events.
Study Overview
Brief Summary
The purpose of this study (E7389-J081-224; hereafter referred to as Study 224) is to evaluate the safety of patients who continue to receive E7389 after completing the Phase II clinical study (E7389-J081-221; hereafter referred to as Study 221) of E7389 for advanced or relapsed breast cancer by intravenously administering E7389.
Detailed Description
Study 224 (Extension Period) was designed to evaluate the safety and efficacy of E7389 by collecting data from subjects who continued receiving E7389 after being transferred from Study 221 (Core Period). Thus, efficacy analyses performed in Study 221 were updated and reported with the additional data collected in Study 224. Objective response rate (ORR) and the number of subjects with adverse events are reported as outcome measures because these were the outcome measures of Study 221 which is a main study in the combined data. Also, safety analyses performed in Study 221 were updated and reported with the additional data collected in Study 224.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 74 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Eribulin Mesylate
Intervention: Eribulin Mesylate (Drug)
Outcomes
Primary Outcomes
Number of Subjects With Adverse Events.
Time Frame: Every week during treatment and up to 30 days after last dose of study treatment
Secondary Outcomes
- Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)(Every 6 weeks)