Clinical trial NCT04202328: T-DM1 in HER2-positive Metastatic/Relapsed Breast Cancer
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Health Insurance Review & Assessment Service
name: Korean Cancer Study Group
First posted: 2019-12-17
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression free Survival, PFS
timeFrame: Until September 30, 2019
measure: Incidence of adverse events
timeFrame: Until September 30, 2019
Secondary outcomes:
measure: Time to Next Treatment, TTNT
timeFrame: Until September 30, 2019
measure: Objective Response Rate, ORR
timeFrame: Until September 30, 2019
measure: Overall Survival, OS
timeFrame: Until September 30, 2019
measure: Disease Control Rate, DCR
timeFrame: Until September 30, 2019
measure: Duration of response
timeFrame: Until September 30, 2019
measure: Adverse events of special interest
timeFrame: Until September 30, 2019
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea, Bucheon ST. Mary's Hospital
city: Busan
country: Korea, Republic of
facility: Dongnam Institute of Radiological&Medical Sciences
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Changwon
country: Korea, Republic of
facility: Gyeongsang National University Changwon Hospital
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital
city: Cheonan
country: Korea, Republic of
facility: Soonchunhyang University Cheonan Hospital
city: Cheonju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Fatima Hospital.
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea Daejeon ST. Mary's Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Daejeon Eulji Medical Center, Eulji University.
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
city: Gyeongju
country: Korea, Republic of
facility: Dongguk University Gyeongju Hospital.
city: Hwaseong-si
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Ilsan
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
city: Ilsan
country: Korea, Republic of
facility: nje University Ilsan Paik Hospital
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea Incheon ST. Mary's Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Cha University Bundang Medical Center
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Hospital of Korea Institute of Radiological and Medical Sciences
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center, Eulji University
city: Seoul
country: Korea, Republic of
facility: Kangdong Kyung Hee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul ST. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: ChungAng University Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Yeouido ST. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea ST. Mary's Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Uijeongbu
country: Korea, Republic of
facility: The Catholic University of Korea Uijeongbu ST. Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
References: