Halaven Patient Registry (Metastatic Breast Cancer, MBC)
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|ClinicalTrials.gov Identifier: NCT03245112|
Recruitment Status : Recruiting
First Posted : August 10, 2017
Last Update Posted : August 16, 2017
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, e.g. Hong Kong, India, Japan, Malaysia, Myanmar, Philippines, South Korea, Singapore, Taiwan and Thailand. According to two large global phase III study reports of Halaven, very few Asian patients participated in these studies. In a phase II study of Halaven with metastatic breast cancer, the clinical efficacy and toxicity were reported only in 80 Japanese patients. Halaven has been granted its marketing authorization in Singapore since February 2011. However, most of other Asian countries including India have had the approval and launched from middle year of 2013 or in early 2014. Limited information of Halaven using in Asian patients are available except several case experience exchange presented by individual medical centers or as personal experience in the past. Some clinical concerns related to Halaven use are raised by clinicians during their clinical practice, such as how Halaven works on Asian patients, which type of patient obtains better clinical benefit from Halaven, and what are the main treatment related toxicities in Asian which may differ from Westerners due to potential ethnic diversity. Further understanding of Halaven related clinical benefit and toxicity in Asian patients through collecting clinical experience among Asian countries becomes necessary and may provide better information to anticipate these concerns.
The proposed "Halaven Patient Registry" (called the "Registry") will be a patient population-based registry to collect therapeutic related information from patients with metastatic breast cancer who were treated with Halaven that was given as a clinical decision by patient's treating physician based on clinical status of a patient and proper indication of Halaven and to gain a better understanding of the use of Halaven in such Asian patients.
|Condition or disease||Intervention/treatment|
|Metastatic Breast Cancer Advanced Breast Cancer||Drug: Eribulin Mesylate|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Retrospective Data Collection and Analysis of the Therapeutic Effect of Eribulin for Advanced Breast Cancer Patients.|
|Actual Study Start Date :||March 3, 2014|
|Estimated Primary Completion Date :||December 31, 2017|
|Estimated Study Completion Date :||December 31, 2017|
- Drug: Eribulin Mesylate
The patients received intravenous eribulin 1.4 mg/m2 over 2-5 minutes on days 1 and 8 of every 21 days.Other Name: Halaven
- Disease Control Rate (DCR) [ Time Frame: 24 months ]he percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention
- Number of patients with adverse events [ Time Frame: 24 months ]An AE may consist of the following: A new event which was not pre-existing at initial study drug administration. A pre-existing event which recurs with increased intensity or increased frequencysubsequent to study drug administration. An event which is present at the time of study drug administration which isexacerbated following initial study drug administration.
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): NCT03245112
|Contact: Fang-Ming Chen, MD, PhDemail@example.com|
|Kaohsiung Chang Gung Memorial Hospital||Recruiting|
|Contact: KUN-MING RAU, MD 07-7317-123 ext 3267 Liu07822@ms57.hinet.net|
|Principal Investigator: KUN-MING RAU, MD|