T-DM1 in HER2-positive Metastatic/Relapsed Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT04202328
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- 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
• Patients who have received T-DM1 therapy outside of the Korea National Health Insurance System
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of adverse events Until September 30, 2019 Number (percentage) of subjects reporting adverse events
Progression free Survival, PFS Until September 30, 2019 Time from the start of T-DM1 to disease progression or death from any cause
- Secondary Outcome Measures
Name Time Method Time to Next Treatment, TTNT Until September 30, 2019 Time from the end of T-DM1 to institution of next systemic therapy
Disease Control Rate, DCR Until September 30, 2019 The proportion of subjects confirmed complete or partial response or stable disease
Adverse events of special interest Until September 30, 2019 Number (percentage) of subjects reporting adverse events of special interest associated with T-DM1
Objective Response Rate, ORR Until September 30, 2019 The proportion of subjects confirmed complete or partial response
Duration of response Until September 30, 2019 Time from documentation of tumor response to disease progression
Overall Survival, OS Until September 30, 2019 Time from the start of T-DM1 to death from any cause
Trial Locations
- Locations (60)
Korea University Ansan Hospital
🇰🇷Ansan, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
Soonchunhyang University Bucheon Hospital
🇰🇷Bucheon, Korea, Republic of
The Catholic University of Korea, Bucheon ST. Mary's Hospital
🇰🇷Bucheon, Korea, Republic of
Dongnam Institute of Radiological&Medical Sciences
🇰🇷Busan, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
Gyeongsang National University Changwon Hospital
🇰🇷Changwon, Korea, Republic of
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