Post-marketing Surveillance for the Clinical Safety and Effectiveness of Eribulin Mesylate in Patients With Inoperable or Recurrent Breast Cancer (Study HAL01S)
To investigate of the clinical safety and effectiveness of eribulin mesylate in patients with inoperable or recurrent breast cancer
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Post-marketing Surveillance for the Clinical Safety and Effectiveness of Eribulin Mesylate in Patients With Inoperable or Recurrent Breast Cancer|
- Effectiveness Diagnosed by Imaging [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Effectiveness diagnosed by imaging, is based on Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. Defined as:
- Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
- Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters
- Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
- Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
- Not Evaluable (NE).
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
|Drug : Eribulin Mesylate||
Drug: Eribulin Mesylate
The usual adult dose of eribulin mesylate is 1.4 mg/m^2 (body surface area) administered intravenously over 2 to 5 minutes, once daily once a week. Treatment shall be continued for 2 consecutive weeks followed by a third week of drug cessation. With each cycle lasting 3 weeks, the treatment shall be repeated. The dose may be reduced, depending on the condition of the individual patient.
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|Study Director:||Toshiyuki Matsuoka||Drug Fostering and Evolution Cordination Department, Eisai Co., Ltd.|