Status:
UNKNOWN
Halaven Patient Registry (Metastatic Breast Cancer, MBC)
Lead Sponsor:
Chang Gung Memorial Hospital
Collaborating Sponsors:
Kaohsiung Breast Cancer Prevention and Education Society (KBCPES)
Eisai Co., Ltd.
Conditions:
Metastatic Breast Cancer
Advanced Breast Cancer
Eligibility:
FEMALE
24-85 years
Brief Summary
Since the first marketing authorization in the world in November 2010 granted by US FDA, Halaven has been approved for clinical use in more than 40 countries worldwide, including many Asian countries,...
Eligibility Criteria
Inclusion
- An eligible patient to be entered into the Registry is defined as:
- Patient with advanced breast cancer.
- Halaven was given or has been treating during the period of 1 Jan 2015 to 31 Dec 2016.
- Halaven was given as single or combination.
- Patient received at least one cycle treatment (a 21-day cycle or 2 doses) of Halaven.
- Patient with at least 80% of the required information of the Registry CRF to be entered. It will be calculated automatically by the Registry system.
- Patient to be selected for the Registry will be based on chorological order of a patient occurred in a study center during the defined period of the Registry, if all other eligibility criteria are met.
Exclusion
- Those who not meet the inclusion criteria will be excluded.
Key Trial Info
Start Date :
March 3 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2017
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03245112
Start Date
March 3 2014
End Date
December 31 2017
Last Update
August 16 2017
Active Locations (1)
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1
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan