Post-marketing Surveillance for interstitial lung disease of ENHERTU in breast cancer patients
Not Applicable
Completed
- Conditions
- HER2-positive unresectable or recurrent breast cancer after prior chemotherapy
- Registration Number
- JPRN-jRCT1080225197
- Lead Sponsor
- DAIICHI SANKYO CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 1500
Inclusion Criteria
All patients who start receiving ENHERTU for injection, during the registration period.
Exclusion Criteria
Patients with a previous history of hypersensitivity to the ingredients of ENHURTS
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>The development of ILD based on the results of adjudication by the external ILD adjudication committee
- Secondary Outcome Measures
Name Time Method safety<br>Treatment-related ILD as reported by the investigator