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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

Tracking Information
First Submitted Date August 8, 2017
First Posted Date August 10, 2017
Last Update Posted Date August 16, 2017
Actual Study Start Date March 3, 2014
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 13, 2017)
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
Original Primary Outcome Measures
 (submitted: August 8, 2017)
Treatment efficacy and Adverse events [ Time Frame: 2 years ]
Observational retrospective study was performed in order to evaluate activity and tolerability of eribulin in real-world patient population.
Change History Complete list of historical versions of study NCT03245112 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 13, 2017)
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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Halaven Patient Registry (Metastatic Breast Cancer, MBC)
Official Title Retrospective Data Collection and Analysis of the Therapeutic Effect of Eribulin for Advanced Breast Cancer Patients.
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.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
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.
Condition
  • Metastatic Breast Cancer
  • Advanced Breast Cancer
Intervention 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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 8, 2017)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2017
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 24 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03245112
Other Study ID Numbers 201700596B0
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Chang Gung Memorial Hospital
Study Sponsor Chang Gung Memorial Hospital
Collaborators
  • Kaohsiung Breast Cancer Prevention and Education Society (KBCPES)
  • Eisai Co., Ltd.
Investigators Not Provided
PRS Account Chang Gung Memorial Hospital
Verification Date April 2017