Post-marketing Surveillance for the Clinical Safety and Effectiveness of Eribulin Mesylate in Patients With Inoperable or Recurrent Breast Cancer (Study HAL01S)
|ClinicalTrials.gov Identifier: NCT01463891|
Recruitment Status : Completed
First Posted : November 2, 2011
Last Update Posted : September 7, 2018
|Condition or disease||Intervention/treatment|
|Inoperable or Recurrent Breast Cancer||Drug: Eribulin Mesylate|
|Study Type :||Observational|
|Actual Enrollment :||963 participants|
|Official Title:||Post-marketing Surveillance for the Clinical Safety and Effectiveness of Eribulin Mesylate in Patients With Inoperable or Recurrent Breast Cancer|
|Actual Study Start Date :||July 19, 2011|
|Actual Primary Completion Date :||December 26, 2012|
|Actual Study Completion Date :||November 27, 2013|
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.
- Effectiveness Diagnosed by Imaging [ Time Frame: 1 year ]
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 nontarget) must have reduction in short axis to less than10 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01463891
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|Study Director:||Toshiyuki Matsuoka||Drug Fostering and Evolution Cordination Department, Eisai Co., Ltd.|