Post-marketing Surveillance for the Clinical Safety and Effectiveness of Eribulin Mesylate in Patients With Inoperable or Recurrent Breast Cancer (Study HAL01S)
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|ClinicalTrials.gov Identifier: NCT01463891|
Recruitment Status : Completed
First Posted : November 2, 2011
Last Update Posted : January 4, 2017
|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|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||November 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01463891
Show 223 Study Locations
|Study Director:||Toshiyuki Matsuoka||Drug Fostering and Evolution Cordination Department, Eisai Co., Ltd.|