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)
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Soonchunhyang University Cheonan Hospital
🇰🇷Cheonan, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Cheonju, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Daejeon Eulji Medical Center, Eulji University.
🇰🇷Daejeon, Korea, Republic of
Konyang University Hospital
🇰🇷Daejeon, Korea, Republic of
Gangneung Asan Hospital
🇰🇷Gangneung, Korea, Republic of
Hallym University Dongtan Sacred Heart Hospital
🇰🇷Hwaseong-si, Korea, Republic of
Dongguk University Gyeongju Hospital.
🇰🇷Gyeongju, Korea, Republic of
The Catholic University of Korea Incheon ST. Mary's Hospital
🇰🇷Incheon, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Korea, Republic of
nje University Ilsan Paik Hospital
🇰🇷Ilsan, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of
Korea Cancer Hospital of Korea Institute of Radiological and Medical Sciences
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Uijeongbu ST. Mary's Hospital
🇰🇷Uijeongbu, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
The Catholic University of Korea ST. Mary's Hospital
🇰🇷Suwon, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
ChungAng University Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Bucheon ST. Mary's Hospital
🇰🇷Bucheon, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Ansan, Korea, Republic of
Soonchunhyang University Bucheon Hospital
🇰🇷Bucheon, Korea, Republic of
Dongnam Institute of Radiological&Medical Sciences
🇰🇷Busan, Korea, Republic of
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
Gyeongsang National University Changwon Hospital
🇰🇷Changwon, Korea, Republic of
Dankook University Hospital
🇰🇷Cheonan, Korea, Republic of
The Catholic University of Korea Daejeon ST. Mary's Hospital
🇰🇷Daejeon, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Daegu Fatima Hospital.
🇰🇷Daegu, Korea, Republic of
Chosun University Hospital
🇰🇷Gwangju, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
National Cancer Center
🇰🇷Goyang, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Soonchunhyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Dongguk University Ilsan Hospital
🇰🇷Ilsan, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷Jinju, Korea, Republic of
Cha University Bundang Medical Center
🇰🇷Seongnam, Korea, Republic of
Nowon Eulji Medical Center, Eulji University
🇰🇷Seoul, Korea, Republic of
SMG-SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Kangdong Kyung Hee University Medical Center
🇰🇷Seoul, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Yeouido ST. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Seoul ST. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of