Trastuzumab Emtansine(T-DM1) After Trastuzumab Deruxtecan(T-DXd) in HER2-Positive Breast Cancer in Korea
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorSeoul National University Hospital
About this trial
Prospective observational study of trastuzumab emtansine immediately after trastuzumab deruxtecan in patients with advanced HER2-positive breast cancer in Korea
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
HER2-positive, advanced (unresectable locally advanced or metastatic) breast cancer
Prior treatment with trastuzumab deruxtecan(T-DXd) in the advanced setting
Intention to treat with Trastuzumab Emtansine (T-DM1) as first therapy upon T-DXd progression
Disqualifiers
Any systemic treatment, other than T-DM1, for breast cancer after trastuzumab deruxtecan (As an exception, patients treated with endocrine agents, not in combination with cytotoxics or antibody-drug conjugates, will be permitted in the study)
Has been previously treated with T-DM1 for advanced breast cancer
Has been previously treated with 4 or more lines of therapy for advanced breast cancer
Half (50%) or more patients will be those who were treated with second-line trastuzumab deruxtecan (i.e. patients at the later line will be capped).
Trial population
* Signed Informed Consent Form, when the patient is alive and not lost to follow- up. * Age ≥ 19 years old. * Histologically or cytologically confirmed, HER2-positive advanced breast cancer which is either locally advanced precluding resection or metastatic. * Prior treatment with T-Dxd in the advanced setting * Intention to treat with T-DM1 as next therapy upon progression from T-Dxd Patients who meet any of the following criteria will be excluded from study entry: * Any systemic treatment, other than T-DM1, for breast cancer after T-Dxd (With an exception, endocrine agents not in combination with cytotoxics or antibody-drug conjugates will be permitted in the study) * Has been previously treated with T-DM1 for advanced breast cancer * Has been previously treated with 4 or more lines of therapy for advanced breast cancer
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
progression-free survival (PFS)
PFS will be assessed by physicians as per routine clinical practice. CT and/or MRI scans will be at baseline and every 2-4 cycles at the treating physician's discretion, reflecting the observational study design.
Time frame
PFS is defined as the time from treatment initiation to the first occurrence of disease progression or death from any cause, whichever occurs first, assessed up to 12 months.Secondary outcomes
1
objective response rate (ORR)
• objective response rate (ORR)
Time frame
12-month2
12-month survival rate
12-month survival rate
Time frame
12-month3
time-to-discontinuation (TTD)
time-to-discontinuation (TTD)
Time frame
12-month4
time-to-next-line-treatment (TTNT)
time-to-next-line-treatment (TTNT), disregarding endocrine treatments as the maintenance
Time frame
12-monthSponsors and contacts
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Source ClinicalTrials.gov