Cancer of Breast, Trastuzumab Deruxtecan, Trastuzumab Emtansine
Conditions
Brief summary
Prospective observational study of trastuzumab emtansine immediately after trastuzumab deruxtecan in patients with advanced HER2-positive breast cancer in Korea
Interventions
None listed
Sponsors
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival (PFS) | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate (ORR) | 12-month | • objective response rate (ORR) |
| 12-month survival rate | 12-month | 12-month survival rate |
| time-to-discontinuation (TTD) | 12-month | time-to-discontinuation (TTD) |
| time-to-next-line-treatment (TTNT) | 12-month | time-to-next-line-treatment (TTNT), disregarding endocrine treatments as the maintenance |
| Duration of therapy (DoT) | 12-month | Duration of therapy (of T-DM1) will be compared to the duration of previous therapy (T-DXd) to ensure the comparability of each treatments reflecting the tumor biology and clinical course. |
| Incidence of Treatment-Emergent Adverse Events | 12-month | Incidence of Treatment-Emergent Adverse Events |
Countries
South Korea
Contacts
CONTACTKyung-Hun Lee, MD, PhD
Outcome results
None listed