T-DM1 in HER2-positive Metastatic/Relapsed Breast Cancer

Study Overview
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Brief Summary
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This is a retrospective, multicenter, non-interventional study for the evaluation of real-world efficacy and safety of T-DM1 in metastatic/relapsed HER2-positive breast cancer as part of the establishment of hospital medical record collection system to evaluate drug effectiveness by Health Insurance Review & Assessment Service (HIRA). The medical records in approximately 1,000 patients of HER2-positive locally-advanced unresectable or metastatic breast cancer, who have received Kadcyla(Trastuzumab Emtansine, T-DM1) previously, will be collected.

Detailed Description
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T-DM1 therapy has shown a survival benefit in previously trastuzumab-treated HER2-positive locally-advanced unresectable or metastatic breast cancer patients from clinical trials. However, the real-world efficacy and safety of T-DM1 in KOREA were not evaluated outside the controlled clinical trials. Therefore, this large multicenter retrospective analysis was designed to evaluate the real-world efficacy and safety of T-DM1 under the Korea National Health Insurance System. The medical records in approximately 1,000 patients with relapsed or De Novo metastatic breast cancer, who have received T-DM1 between Aug 03, 2017 and Dec 31, 2018 will be collected. Eligibility criteria included age ≥ 19 years, histologically confirmed HER2-positive, relapsed after primary surgery or initially metastatic breast cancer, and previous trastuzumab treated. Efficacy was evaluated by overall survival, progression free survival, time to progression, objective response rate, disease control rate, duration of response and time to next treatment. Safety was evaluated by hematologic or non-non hematologic toxicities and adverse events of special interest with T-DM1 therapy.

Official Title
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A Retrospective Study for Evaluation of Real-world Efficacy and Safety of T-DM1 in HER2-positive Locally-advanced Unresectable or Metastatic Breast Cancer

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥19 years at the time of study registration Participants must have histologically confirmed HER2-positive breast cancer Locally advanced unresectable or metastatic patients Patients who have received T-DM1 therapy between Aug 2017 and December 2018 under the Korea National Health Insurance System Exclusion Criteria: • Patients who have received T-DM1 therapy outside of the Korea National Health Insurance System
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free Survival, PFS | Time from the start of T-DM1 to disease progression or death from any cause | Until September 30, 2019 | 
| Incidence of adverse events | Number (percentage) of subjects reporting adverse events | Until September 30, 2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Next Treatment, TTNT | Time from the end of T-DM1 to institution of next systemic therapy | Until September 30, 2019 | 
| Objective Response Rate, ORR | The proportion of subjects confirmed complete or partial response | Until September 30, 2019 | 
| Overall Survival, OS | Time from the start of T-DM1 to death from any cause | Until September 30, 2019 | 
| Disease Control Rate, DCR | The proportion of subjects confirmed complete or partial response or stable disease | Until September 30, 2019 | 
| Duration of response | Time from documentation of tumor response to disease progression | Until September 30, 2019 | 
| Adverse events of special interest | Number (percentage) of subjects reporting adverse events of special interest associated with T-DM1 | Until September 30, 2019 |