T-DM1 in HER2-positive Metastatic/Relapsed Breast Cancer
A Retrospective Study for Evaluation of Real-world Efficacy and Safety of T-DM1 in HER2-positive Locally-advanced Unresectable or Metastatic Breast Cancer
1 other identifier
observational
1,000
1 country
60
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2019
Shorter than P25 for all trials
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2019
CompletedFirst Posted
Study publicly available on registry
December 17, 2019
CompletedStudy Start
First participant enrolled
December 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2020
CompletedDecember 19, 2019
December 1, 2019
8 months
December 9, 2019
December 17, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
Time to Next Treatment, TTNT
Until September 30, 2019
Objective Response Rate, ORR
Until September 30, 2019
Overall Survival, OS
Until September 30, 2019
Disease Control Rate, DCR
Until September 30, 2019
Duration of response
Until September 30, 2019
- +1 more secondary outcomes
Eligibility Criteria
Patients with locally-advanced unresectable or metastatic HER2-positive breast cancer, who have received T-DM1 therapy between Aug 2017 and December 2018 under the Korea National Health Insurance System
You may qualify if:
- 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
You may not qualify if:
- Patients who have received T-DM1 therapy outside of the Korea National Health Insurance System
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Samsung Medical Centerlead
- Health Insurance Review & Assessment Servicecollaborator
- Korean Cancer Study Groupcollaborator
Study Sites (60)
Korea University Ansan Hospital
Ansan, 15355, South Korea
Hallym University Sacred Heart Hospital
Anyang, 14068, South Korea
Soonchunhyang University Bucheon Hospital
Bucheon-si, 14584, South Korea
The Catholic University of Korea, Bucheon ST. Mary's Hospital
Bucheon-si, 14647, South Korea
Dongnam Institute of Radiological&Medical Sciences
Busan, 46033, South Korea
Inje University Busan Paik Hospital
Busan, 47392, South Korea
Dong-A University Hospital
Busan, 49201, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Kosin University Gospel Hospital
Busan, 49267, South Korea
Gyeongsang National University Changwon Hospital
Changwon, 51472, South Korea
Dankook University Hospital
Cheonan, 31116, South Korea
Soonchunhyang University Cheonan Hospital
Cheonan, 31151, South Korea
Chungbuk National University Hospital
Cheonju, 28644, South Korea
Daegu Fatima Hospital.
Daegu, 41199, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
Yeungnam University Medical Center
Daegu, 42415, South Korea
Daegu Catholic University Medical Center
Daegu, 42472, South Korea
Keimyung University Dongsan Medical Center
Daegu, 42601, South Korea
The Catholic University of Korea Daejeon ST. Mary's Hospital
Daejeon, 34943, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
Daejeon Eulji Medical Center, Eulji University.
Daejeon, 35233, South Korea
Konyang University Hospital
Daejeon, 35365, South Korea
Gangneung Asan Hospital
Gangneung, 25440, South Korea
National Cancer Center
Goyang, 10408, South Korea
Chosun University Hospital
Gwangju, 61453, South Korea
Dongguk University Gyeongju Hospital.
Gyeongju, 38067, South Korea
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, 18450, South Korea
Chonnam National University Hwasun Hospital
Hwasun, 58128, South Korea
Dongguk University Ilsan Hospital
Ilsan, 10326, South Korea
nje University Ilsan Paik Hospital
Ilsan, 10380, South Korea
The Catholic University of Korea Incheon ST. Mary's Hospital
Incheon, 21431, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Chonbuk National University Hospital
Jeonju, 54907, South Korea
Gyeongsang National University Hospital
Jinju, 52727, South Korea
Cha University Bundang Medical Center
Seongnam, 13496, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Korea Cancer Hospital of Korea Institute of Radiological and Medical Sciences
Seoul, 01812, South Korea
Nowon Eulji Medical Center, Eulji University
Seoul, 01830, South Korea
Kangdong Kyung Hee University Medical Center
Seoul, 02447, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Soonchunhyang University Seoul Hospital
Seoul, 04401, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Gangnam Severance Hospital
Seoul, 06273, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul ST. Mary's Hospital
Seoul, 06591, South Korea
ChungAng University Hospital
Seoul, 06973, South Korea
SMG-SNU Boramae Medical Center
Seoul, 07061, South Korea
The Catholic University of Korea Yeouido ST. Mary's Hospital
Seoul, 07345, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441, South Korea
Ewha Womans University Mokdong Hospital
Seoul, 07985, South Korea
The Catholic University of Korea ST. Mary's Hospital
Suwon, 16247, South Korea
Ajou University Hospital
Suwon, 16499, South Korea
The Catholic University of Korea Uijeongbu ST. Mary's Hospital
Uijeongbu-si, 11765, South Korea
Ulsan University Hospital
Ulsan, 44033, South Korea
Pusan National University Yangsan Hospital
Yangsan, 50612, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 9, 2019
First Posted
December 17, 2019
Study Start
December 19, 2019
Primary Completion
July 31, 2020
Study Completion
July 31, 2020
Last Updated
December 19, 2019
Record last verified: 2019-12