EN-SEMBLE

JRCT ID: jRCT1030220506

Registered date:12/12/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: HER2-positive unresectable and/or recurrent breast cancer
• Date of first enrollment: 12/12/2022
• Target sample size: 1200
• Study type: Observational

Outcome(s)

Primary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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).

• Exclude criteria: 1)Patients who are deemed inappropriate by the investigator.

Related Information

• Primary Sponsor: Tsurutani Junji