- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04202328
T-DM1 in HER2-positive Metastatic/Relapsed Breast Cancer
December 17, 2019 updated by: Yeon Hee Park, Samsung Medical Center
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Park Yeon Hee
- Phone Number: +82-2-3410-1780
- Email: yhparkhmo@skku.edu
Study Locations
-
-
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Ansan, Korea, Republic of, 15355
- Korea University Ansan Hospital
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Anyang, Korea, Republic of, 14068
- Hallym University Sacred Heart Hospital
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Bucheon, Korea, Republic of, 14584
- Soonchunhyang University Bucheon Hospital
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Bucheon, Korea, Republic of, 14647
- The Catholic University of Korea, Bucheon St. Mary's Hospital
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Busan, Korea, Republic of, 49241
- Pusan National University Hospital
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Busan, Korea, Republic of, 49201
- Dong-A University Hospital
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Busan, Korea, Republic of, 47392
- Inje University Busan Paik Hospital
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Busan, Korea, Republic of, 49267
- Kosin University Gospel Hospital
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Busan, Korea, Republic of, 46033
- Dongnam Institute of Radiological&Medical Sciences
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Changwon, Korea, Republic of, 51472
- Gyeongsang National University Changwon Hospital
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Cheonan, Korea, Republic of, 31116
- Dankook University Hospital
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Cheonan, Korea, Republic of, 31151
- Soonchunhyang University Cheonan Hospital
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Cheonju, Korea, Republic of, 28644
- Chungbuk National University Hospital
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Daegu, Korea, Republic of, 41404
- Kyungpook National University Chilgok Hospital
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Daegu, Korea, Republic of, 42415
- Yeungnam University Medical Center
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Daegu, Korea, Republic of, 42472
- Daegu Catholic University Medical Center
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Daegu, Korea, Republic of, 42601
- Keimyung University Dongsan Medical Center
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Daegu, Korea, Republic of, 41199
- Daegu Fatima Hospital.
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Daejeon, Korea, Republic of, 35015
- Chungnam National University Hospital
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Daejeon, Korea, Republic of, 35365
- Konyang University Hospital
-
Daejeon, Korea, Republic of, 34943
- The Catholic University of Korea Daejeon ST. Mary's hospital
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Daejeon, Korea, Republic of, 35233
- Daejeon Eulji Medical Center, Eulji University.
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Gangneung, Korea, Republic of, 25440
- Gangneung Asan Hospital
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Goyang, Korea, Republic of, 10408
- National Cancer Center
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Gwangju, Korea, Republic of, 61453
- Chosun university hospital
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Gyeongju, Korea, Republic of, 38067
- Dongguk University Gyeongju Hospital.
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Hwaseong-si, Korea, Republic of, 18450
- Hallym University Dongtan Sacred Heart Hospital
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Hwasun, Korea, Republic of, 58128
- Chonnam National University Hwasun Hospital
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Ilsan, Korea, Republic of, 10326
- Dongguk University Ilsan Hospital
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Ilsan, Korea, Republic of, 10380
- nje University Ilsan Paik Hospital
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Incheon, Korea, Republic of, 21565
- Gachon University Gil Medical Center
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Incheon, Korea, Republic of, 22332
- Inha University Hospital
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Incheon, Korea, Republic of, 21431
- The Catholic University of Korea Incheon St. Mary's Hospital
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Jeonju, Korea, Republic of, 54907
- Chonbuk National University Hospital
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Jinju, Korea, Republic of, 52727
- Gyeongsang National University Hospital
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Seongnam, Korea, Republic of, 13620
- Seoul National University Bundang Hospital
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Seongnam, Korea, Republic of, 13496
- Cha University Bundang Medical Center
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
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Seoul, Korea, Republic of, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, Korea, Republic of, 05030
- Konkuk University Medical Center
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Seoul, Korea, Republic of, 05505
- Asan Medical Center
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Seoul, Korea, Republic of, 02841
- Korea University Anam Hospital
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Seoul, Korea, Republic of, 07441
- Hallym University Kangnam Sacred Heart Hospital
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Seoul, Korea, Republic of, 07985
- Ewha Womans University Mokdong Hospital
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Seoul, Korea, Republic of, 01830
- Nowon Eulji Medical Center, Eulji University
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Seoul, Korea, Republic of, 06351
- Samsung Medical Center
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Seoul, Korea, Republic of, 03181
- Kangbuk Samsung Hospital
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Seoul, Korea, Republic of, 06591
- The Catholic University of Korea Seoul St. Mary's Hospital
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Seoul, Korea, Republic of, 07061
- SMG-SNU Boramae Medical Center
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Seoul, Korea, Republic of, 06273
- Gangnam Severance Hospital
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Seoul, Korea, Republic of, 06973
- Chungang University Hospital
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Seoul, Korea, Republic of, 07345
- The Catholic University of Korea Yeouido St. Mary's Hospital
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Seoul, Korea, Republic of, 04401
- SoonChunHyang University Seoul Hospital
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Seoul, Korea, Republic of, 01812
- Korea Cancer Hospital of Korea Institute of Radiological and Medical Sciences
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Seoul, Korea, Republic of, 02447
- Kangdong Kyung Hee University Medical Center
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Suwon, Korea, Republic of, 16499
- Ajou University Hospital
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Suwon, Korea, Republic of, 16247
- The Catholic University of Korea St. Mary's Hospital
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Uijeongbu, Korea, Republic of, 11765
- The Catholic University of Korea Uijeongbu St. Mary's Hospital
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Ulsan, Korea, Republic of, 44033
- Ulsan University Hospital
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Yangsan, Korea, Republic of, 50612
- Pusan National University Yangsan Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
• Patients who have received T-DM1 therapy outside of the Korea National Health Insurance System
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free Survival, PFS
Time Frame: Until September 30, 2019
|
Time from the start of T-DM1 to disease progression or death from any cause
|
Until September 30, 2019
|
Incidence of adverse events
Time Frame: Until September 30, 2019
|
Number (percentage) of subjects reporting adverse events
|
Until September 30, 2019
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Next Treatment, TTNT
Time Frame: Until September 30, 2019
|
Time from the end of T-DM1 to institution of next systemic therapy
|
Until September 30, 2019
|
Objective Response Rate, ORR
Time Frame: Until September 30, 2019
|
The proportion of subjects confirmed complete or partial response
|
Until September 30, 2019
|
Overall Survival, OS
Time Frame: Until September 30, 2019
|
Time from the start of T-DM1 to death from any cause
|
Until September 30, 2019
|
Disease Control Rate, DCR
Time Frame: Until September 30, 2019
|
The proportion of subjects confirmed complete or partial response or stable disease
|
Until September 30, 2019
|
Duration of response
Time Frame: Until September 30, 2019
|
Time from documentation of tumor response to disease progression
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Until September 30, 2019
|
Adverse events of special interest
Time Frame: Until September 30, 2019
|
Number (percentage) of subjects reporting adverse events of special interest associated with T-DM1
|
Until September 30, 2019
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 19, 2019
Primary Completion (Anticipated)
July 31, 2020
Study Completion (Anticipated)
July 31, 2020
Study Registration Dates
First Submitted
December 9, 2019
First Submitted That Met QC Criteria
December 16, 2019
First Posted (Actual)
December 17, 2019
Study Record Updates
Last Update Posted (Actual)
December 19, 2019
Last Update Submitted That Met QC Criteria
December 17, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KCSG BR19-15
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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