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Halaven Patient Registry (Metastatic Breast Cancer, MBC)

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ClinicalTrials.gov Identifier: NCT03245112
Recruitment Status : Unknown
Verified April 2017 by Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : August 10, 2017
Last Update Posted : August 16, 2017
Sponsor:
Collaborators:
Kaohsiung Breast Cancer Prevention and Education Society (KBCPES)
Eisai Co., Ltd.
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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, 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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer


Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   24 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The advanced or metastatic breast cancer patient who received at least 1 course Halaven therapy was eligible to this study.
Criteria

Inclusion Criteria:

  • An eligible patient to be entered into the Registry is defined as:

    1. Patient with advanced breast cancer.
    2. Halaven was given or has been treating during the period of 1 Jan 2015 to 31 Dec 2016.
    3. Halaven was given as single or combination.
    4. Patient received at least one cycle treatment (a 21-day cycle or 2 doses) of Halaven.
    5. 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 Criteria:

  • Those who not meet the inclusion criteria will be excluded.

Information from the National Library of Medicine

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


Contacts
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Contact: Fang-Ming Chen, MD, PhD 03-3164-990 kbcs0609@gmail.com

Locations
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Taiwan
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan
Contact: KUN-MING RAU, MD    07-7317-123 ext 3267    Liu07822@ms57.hinet.net   
Principal Investigator: KUN-MING RAU, MD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Kaohsiung Breast Cancer Prevention and Education Society (KBCPES)
Eisai Co., Ltd.

Additional Information:

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03245112     History of Changes
Other Study ID Numbers: 201700596B0
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases