HER2-positive unresectable and/or recurrent breast cancer
Conditions
Interventions
None listed
Sponsors
Tsurutani Junji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients who received T-DXd for HER2-positive unresectable and/or recurrent breast cancer between May 25, 2020 and November 30, 2021. 2)Patients enrolled in the "Post-marketing Surveillance for interstitial lung disease of ENHERTU in breast cancer patients" 3)Patients who started post-treatment after discontinuation of T-DXd 4)Patients who are 18 years of age or older at the start of post-treatment. 5)Patients who have given written informed consent (however, patients who cannot give written informed consent due to death or loss of follow-up will be allowed to opt out).
Exclusion criteria
Exclusion criteria: 1)Patients who are deemed inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Distribution of post-treatment regimen 2.Effectiveness and safety endpoints in all subjects and by post-treatment regimen -Progression Free Survival (PFS) -Time to Treatment Failure (TTF) -Time to Next Treatment (TTNT) -Overall Survival (OS) -Objective response rate (ORR) -PFS2 -TTF2 -Incidence rate of Interstitial lung disease (ILD) 3.Exploratory endpoint -PFS2 that the starting point is regarded as the first dose date of T-DXd treatment -TTF2 that the starting point is regarded as the first dose date of T-DXd treatment 4.Distribution and effectiveness and safety of post-treatment regimens in subgroups | — |
Contacts
Public ContactReiko Shibata
EPS Corporation
Outcome results
None listed