Breast Cancer Clinical Trial
Official title:
A Retrospective Study for Evaluation of Real-world Efficacy and Safety of T-DM1 in HER2-positive Locally-advanced Unresectable or Metastatic Breast Cancer
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.
Status | Not yet recruiting |
Enrollment | 1000 |
Est. completion date | July 31, 2020 |
Est. primary completion date | July 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. Age =19 years at the time of study registration 2. Participants must have histologically confirmed HER2-positive breast cancer 3. Locally advanced unresectable or metastatic patients 4. 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | 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 | Dong-A University Hospital | Busan | |
Korea, Republic of | Dongnam Institute of Radiological&Medical Sciences | Busan | |
Korea, Republic of | Inje University Busan Paik Hospital | Busan | |
Korea, Republic of | Kosin University Gospel Hospital | Busan | |
Korea, Republic of | Pusan National University Hospital | Busan | |
Korea, Republic of | Gyeongsang National University Changwon Hospital | Changwon | |
Korea, Republic of | Dankook University Hospital | Cheonan | |
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 | Daegu Fatima Hospital. | Daegu | |
Korea, Republic of | Keimyung University Dongsan Medical Center | Daegu | |
Korea, Republic of | Kyungpook National University Chilgok Hospital | Daegu | |
Korea, Republic of | Yeungnam University Medical Center | Daegu | |
Korea, Republic of | Chungnam National University Hospital | Daejeon | |
Korea, Republic of | Daejeon Eulji Medical Center, Eulji University. | Daejeon | |
Korea, Republic of | Konyang University Hospital | Daejeon | |
Korea, Republic of | The Catholic University of Korea Daejeon ST. Mary's Hospital | Daejeon | |
Korea, Republic of | Gangneung Asan Hospital | Gangneung | |
Korea, Republic of | National Cancer Center | Goyang | |
Korea, Republic of | Chosun University Hospital | Gwangju | |
Korea, Republic of | Dongguk University Gyeongju Hospital. | Gyeongju | |
Korea, Republic of | Hallym University Dongtan Sacred Heart Hospital | Hwaseong-si | |
Korea, Republic of | Chonnam National University Hwasun Hospital | Hwasun | |
Korea, Republic of | Dongguk University Ilsan Hospital | Ilsan | |
Korea, Republic of | nje University Ilsan Paik Hospital | Ilsan | |
Korea, Republic of | Gachon University Gil Medical Center | Incheon | |
Korea, Republic of | Inha University Hospital | Incheon | |
Korea, Republic of | The Catholic University of Korea Incheon ST. Mary's Hospital | Incheon | |
Korea, Republic of | Chonbuk National University Hospital | Jeonju | |
Korea, Republic of | Gyeongsang National University Hospital | Jinju | |
Korea, Republic of | Cha University Bundang Medical Center | Seongnam | |
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | ChungAng University Hospital | Seoul | |
Korea, Republic of | Ewha Womans University Mokdong Hospital | Seoul | |
Korea, Republic of | Gangnam Severance Hospital | Seoul | |
Korea, Republic of | Hallym University Kangnam Sacred Heart Hospital | Seoul | |
Korea, Republic of | Kangbuk Samsung Hospital | Seoul | |
Korea, Republic of | Kangdong Kyung Hee University Medical Center | Seoul | |
Korea, Republic of | Konkuk University Medical Center | Seoul | |
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 | Nowon Eulji Medical Center, Eulji University | Seoul | |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | |
Korea, Republic of | SMG-SNU Boramae Medical Center | Seoul | |
Korea, Republic of | Soonchunhyang University Seoul Hospital | Seoul | |
Korea, Republic of | The Catholic University of Korea Seoul ST. Mary's Hospital | Seoul | |
Korea, Republic of | The Catholic University of Korea Yeouido ST. Mary's Hospital | Seoul | |
Korea, Republic of | Ajou University Hospital | Suwon | |
Korea, Republic of | The Catholic University of Korea ST. Mary's Hospital | Suwon | |
Korea, Republic of | The Catholic University of Korea Uijeongbu ST. Mary's Hospital | Uijeongbu | |
Korea, Republic of | Ulsan University Hospital | Ulsan | |
Korea, Republic of | Pusan National University Yangsan Hospital | Yangsan |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center | Health Insurance Review & Assessment Service, Korean Cancer Study Group |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression free Survival, PFS | Time from the start of T-DM1 to disease progression or death from any cause | Until September 30, 2019 | |
Primary | Incidence of adverse events | Number (percentage) of subjects reporting adverse events | Until September 30, 2019 | |
Secondary | Time to Next Treatment, TTNT | Time from the end of T-DM1 to institution of next systemic therapy | Until September 30, 2019 | |
Secondary | Objective Response Rate, ORR | The proportion of subjects confirmed complete or partial response | Until September 30, 2019 | |
Secondary | Overall Survival, OS | Time from the start of T-DM1 to death from any cause | Until September 30, 2019 | |
Secondary | Disease Control Rate, DCR | The proportion of subjects confirmed complete or partial response or stable disease | Until September 30, 2019 | |
Secondary | Duration of response | Time from documentation of tumor response to disease progression | Until September 30, 2019 | |
Secondary | Adverse events of special interest | Number (percentage) of subjects reporting adverse events of special interest associated with T-DM1 | Until September 30, 2019 |
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