An observational study in Breast Cancer, sponsored by Samsung Medical Center. Status unknown at 60 sites in South Korea. Per ClinicalTrials.gov, last updated 2019-12-19.
Sponsored by Samsung Medical Center · Observational
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.
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.
12,820 studies on the registry are indexed under Breast Neoplasms; 2,923 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 185 across 2,712 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Samsung Medical Center is the lead sponsor of 1,005 studies on the registry; 148 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Progression free Survival, PFS
Time from the start of T-DM1 to disease progression or death from any cause
Time frame: Until September 30, 2019
Incidence of adverse events
Number (percentage) of subjects reporting adverse events
Time frame: Until September 30, 2019
Time to Next Treatment, TTNT
Time from the end of T-DM1 to institution of next systemic therapy
Time frame: Until September 30, 2019
Objective Response Rate, ORR
The proportion of subjects confirmed complete or partial response
Time frame: Until September 30, 2019
Overall Survival, OS
Time from the start of T-DM1 to death from any cause
Time frame: Until September 30, 2019
Disease Control Rate, DCR
The proportion of subjects confirmed complete or partial response or stable disease
Time frame: Until September 30, 2019
Duration of response
Time from documentation of tumor response to disease progression
Time frame: Until September 30, 2019
Adverse events of special interest
Number (percentage) of subjects reporting adverse events of special interest associated with T-DM1
Time frame: Until September 30, 2019
This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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