Breast CancerNCT04202328
T-DM1 in HER2-positive Metastatic/Relapsed Breast Cancer
An observational study of Breast Cancer, run by Samsung Medical Center at 60 sites in South Korea.
Trial 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 \&… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- How many people
- 1,000 participants
- Where
- 60 sitesSouth Korea
- Study dates
- 19 Dec 2019to 31 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients who have received T-DM1 therapy outside of the Korea National Health Insurance System
Trial locations and contacts
60 sites in 1 country.
60 sites in 1 country
South Korea60 sites
Korea University Ansan Hospital
Ansan, 15355
Hallym University Sacred Heart Hospital
Anyang, 14068
Soonchunhyang University Bucheon Hospital
Bucheon-si, 14584
The Catholic University of Korea, Bucheon ST. Mary's Hospital
Bucheon-si, 14647
Dongnam Institute of Radiological&Medical Sciences
Busan, 46033
Inje University Busan Paik Hospital
Busan, 47392
Dong-A University Hospital
Busan, 49201
Pusan National University Hospital
Busan, 49241
Kosin University Gospel Hospital
Busan, 49267
Gyeongsang National University Changwon Hospital
Changwon, 51472
Dankook University Hospital
Cheonan, 31116
Soonchunhyang University Cheonan Hospital
Cheonan, 31151
Chungbuk National University Hospital
Cheonju, 28644
Daegu Fatima Hospital.
Daegu, 41199
Kyungpook National University Chilgok Hospital
Daegu, 41404
Yeungnam University Medical Center
Daegu, 42415
Daegu Catholic University Medical Center
Daegu, 42472
Keimyung University Dongsan Medical Center
Daegu, 42601
The Catholic University of Korea Daejeon ST. Mary's Hospital
Daejeon, 34943
Chungnam National University Hospital
Daejeon, 35015
Daejeon Eulji Medical Center, Eulji University.
Daejeon, 35233
Konyang University Hospital
Daejeon, 35365
Gangneung Asan Hospital
Gangneung, 25440
National Cancer Center
Goyang, 10408
Chosun University Hospital
Gwangju, 61453
Dongguk University Gyeongju Hospital.
Gyeongju, 38067
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, 18450
Chonnam National University Hwasun Hospital
Hwasun, 58128
Dongguk University Ilsan Hospital
Ilsan, 10326
nje University Ilsan Paik Hospital
Ilsan, 10380
The Catholic University of Korea Incheon ST. Mary's Hospital
Incheon, 21431
Gachon University Gil Medical Center
Incheon, 21565
Inha University Hospital
Incheon, 22332
Chonbuk National University Hospital
Jeonju, 54907
Gyeongsang National University Hospital
Jinju, 52727
Cha University Bundang Medical Center
Seongnam, 13496
Seoul National University Bundang Hospital
Seongnam, 13620
Korea Cancer Hospital of Korea Institute of Radiological and Medical Sciences
Seoul, 01812
Nowon Eulji Medical Center, Eulji University
Seoul, 01830
Kangdong Kyung Hee University Medical Center
Seoul, 02447
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 03080
Kangbuk Samsung Hospital
Seoul, 03181
Severance Hospital, Yonsei University Health System
Seoul, 03722
Soonchunhyang University Seoul Hospital
Seoul, 04401
Konkuk University Medical Center
Seoul, 05030
Asan Medical Center
Seoul, 05505
Gangnam Severance Hospital
Seoul, 06273
Samsung Medical Center
Seoul, 06351
The Catholic University of Korea Seoul ST. Mary's Hospital
Seoul, 06591
ChungAng University Hospital
Seoul, 06973
SMG-SNU Boramae Medical Center
Seoul, 07061
The Catholic University of Korea Yeouido ST. Mary's Hospital
Seoul, 07345
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441
Ewha Womans University Mokdong Hospital
Seoul, 07985
The Catholic University of Korea ST. Mary's Hospital
Suwon, 16247
Ajou University Hospital
Suwon, 16499
The Catholic University of Korea Uijeongbu ST. Mary's Hospital
Uijeongbu-si, 11765
Ulsan University Hospital
Ulsan, 44033
Pusan National University Yangsan Hospital
Yangsan, 50612
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free Survival, PFS
Time from the start of T-DM1 to disease progression or death from any cause
Measured: Until September 30, 2019
Incidence of adverse events
Number (percentage) of subjects reporting adverse events
Measured: Until September 30, 2019
Secondary outcomes (6)
Time to Next Treatment, TTNT
Time from the end of T-DM1 to institution of next systemic therapy
Measured: Until September 30, 2019
Objective Response Rate, ORR
The proportion of subjects confirmed complete or partial response
Measured: Until September 30, 2019
Overall Survival, OS
Time from the start of T-DM1 to death from any cause
Measured: Until September 30, 2019
Disease Control Rate, DCR
The proportion of subjects confirmed complete or partial response or stable disease
Measured: Until September 30, 2019
Duration of response
Time from documentation of tumor response to disease progression
Measured: Until September 30, 2019
Adverse events of special interest
Number (percentage) of subjects reporting adverse events of special interest associated with T-DM1
Measured: Until September 30, 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start19 Dec 2019 (estimated)
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Health Insurance Review & Assessment Service, Korean Cancer Study Group
- Responsible party
- Principal investigator, Yeon Hee Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202328
- Sponsor's protocol ID
- KCSG BR19-15
- Status last verified
- Dec 2019
- First submitted
- 9 Dec 2019
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04202328
- Acronym / sponsor ID
- KCSG BR19-15
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Health Insurance Review & Assessment Service, Korean Cancer Study Group
- Study start
- 19 Dec 2019 (estimated)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 17 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who have received T-DM1 therapy outside of the Korea National Health Insurance System
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Incidence of adverse events
Time frame: Until September 30, 2019
Number (percentage) of subjects reporting adverse events
6 secondary outcomes
Time to Next Treatment, TTNT
Time frame: Until September 30, 2019
Objective Response Rate, ORR
Time frame: Until September 30, 2019
Overall Survival, OS
Time frame: Until September 30, 2019
Disease Control Rate, DCR
Time frame: Until September 30, 2019
Duration of response
Time frame: Until September 30, 2019
Adverse events of special interest
Time frame: Until September 30, 2019
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
60 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Samsung Medical Center at 60 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Park Yeon Hee (+82-2-3410-1780, yhparkhmo@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free Survival, PFS (time frame: Until September 30, 2019). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2019.