T-DM1 in HER2-positive Metastatic/Relapsed Breast Cancer

NCT ID: NCT04202328

Last Updated: 2019-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-19

Study Completion Date

2020-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Health Insurance Review & Assessment Service

UNKNOWN

Sponsor Role collaborator

Korean Cancer Study Group

OTHER

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yeon Hee Park

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ulsan University Hospital

Ulsan, , South Korea

Site Status

Pusan National University Yangsan Hospital

Yangsan, , South Korea

Site Status

Korea University Ansan Hospital

Ansan, , South Korea

Site Status

Hallym University Sacred Heart Hospital

Anyang, , South Korea

Site Status

Soonchunhyang University Bucheon Hospital

Bucheon-si, , South Korea

Site Status

The Catholic University of Korea, Bucheon ST. Mary's Hospital

Bucheon-si, , South Korea

Site Status

Dongnam Institute of Radiological&Medical Sciences

Busan, , South Korea

Site Status

Inje University Busan Paik Hospital

Busan, , South Korea

Site Status

Dong-A University Hospital

Busan, , South Korea

Site Status

Pusan National University Hospital

Busan, , South Korea

Site Status

Kosin University Gospel Hospital

Busan, , South Korea

Site Status

Gyeongsang National University Changwon Hospital

Changwon, , South Korea

Site Status

Dankook University Hospital

Cheonan, , South Korea

Site Status

Soonchunhyang University Cheonan Hospital

Cheonan, , South Korea

Site Status

Chungbuk National University Hospital

Cheonju, , South Korea

Site Status

Daegu Fatima Hospital.

Daegu, , South Korea

Site Status

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Site Status

Yeungnam University Medical Center

Daegu, , South Korea

Site Status

Daegu Catholic University Medical Center

Daegu, , South Korea

Site Status

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Site Status

The Catholic University of Korea Daejeon ST. Mary's Hospital

Daejeon, , South Korea

Site Status

Chungnam National University Hospital

Daejeon, , South Korea

Site Status

Daejeon Eulji Medical Center, Eulji University.

Daejeon, , South Korea

Site Status

Konyang University Hospital

Daejeon, , South Korea

Site Status

Gangneung Asan Hospital

Gangneung, , South Korea

Site Status

National Cancer Center

Goyang, , South Korea

Site Status

Chosun University Hospital

Gwangju, , South Korea

Site Status

Dongguk University Gyeongju Hospital.

Gyeongju, , South Korea

Site Status

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, , South Korea

Site Status

Chonnam National University Hwasun Hospital

Hwasun, , South Korea

Site Status

Dongguk University Ilsan Hospital

Ilsan, , South Korea

Site Status

nje University Ilsan Paik Hospital

Ilsan, , South Korea

Site Status

The Catholic University of Korea Incheon ST. Mary's Hospital

Incheon, , South Korea

Site Status

Gachon University Gil Medical Center

Incheon, , South Korea

Site Status

Inha University Hospital

Incheon, , South Korea

Site Status

Chonbuk National University Hospital

Jeonju, , South Korea

Site Status

Gyeongsang National University Hospital

Jinju, , South Korea

Site Status

Cha University Bundang Medical Center

Seongnam, , South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Korea Cancer Hospital of Korea Institute of Radiological and Medical Sciences

Seoul, , South Korea

Site Status

Nowon Eulji Medical Center, Eulji University

Seoul, , South Korea

Site Status

Kangdong Kyung Hee University Medical Center

Seoul, , South Korea

Site Status

Korea University Anam Hospital

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

Soonchunhyang University Seoul Hospital

Seoul, , South Korea

Site Status

Konkuk University Medical Center

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Gangnam Severance Hospital

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

The Catholic University of Korea Seoul ST. Mary's Hospital

Seoul, , South Korea

Site Status

ChungAng University Hospital

Seoul, , South Korea

Site Status

SMG-SNU Boramae Medical Center

Seoul, , South Korea

Site Status

The Catholic University of Korea Yeouido ST. Mary's Hospital

Seoul, , South Korea

Site Status

Hallym University Kangnam Sacred Heart Hospital

Seoul, , South Korea

Site Status

Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Site Status

The Catholic University of Korea ST. Mary's Hospital

Suwon, , South Korea

Site Status

Ajou University Hospital

Suwon, , South Korea

Site Status

The Catholic University of Korea Uijeongbu ST. Mary's Hospital

Uijeongbu-si, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Park Yeon Hee

Role: CONTACT

Phone: +82-2-3410-1780

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KCSG BR19-15

Identifier Type: -

Identifier Source: org_study_id