Halaven Patient Registry (Metastatic Breast Cancer, MBC)

Retrospective Data Collection and Analysis of the Therapeutic Effect of Eribulin for Advanced Breast Cancer Patients.

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.

Study Overview

• Status: Unknown
• Conditions: Advanced Breast Cancer; Metastatic Breast Cancer
• Intervention / Treatment: Drug: Eribulin Mesylate

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Fang-Ming Chen, MD, PhD; Phone Number: 03-3164-990; Email: kbcs0609@gmail.com

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • Recruiting
    • Kaohsiung Chang Gung Memorial Hospital
    • Contact: KUN-MING RAU, MD; Phone Number: 3267 07-7317-123; Email: Liu07822@ms57.hinet.net
    • Principal Investigator: KUN-MING RAU, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Control Rate (DCR)	he percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with adverse events	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.	24 months

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Collaborators: Eisai Co., Ltd.; Kaohsiung Breast Cancer Prevention and Education Society (KBCPES)

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2014
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): December 31, 2017

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 10, 2017

Study Record Updates

• Last Update Posted (Actual): August 16, 2017
• Last Update Submitted That Met QC Criteria: August 13, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 201700596B0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No