Post-marketing Surveillance for interstitial lung disease of ENHERTU in breast cancer patients

Post-marketing Surveillance for interstitial lung disease of ENHERTU FOR INTRAVENOUS DRIP INFUSION 100mg in unresectable and/or recurrent breast cancer patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080225197

Enrollment

1500

Registered

2020-05-20

Start date

2020-05-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2-positive unresectable or recurrent breast cancer after prior chemotherapy

Interventions

investigational material(s) Generic name etc : Trastuzumab Deruxtecan (Genetical Recombination) INN of investigational material : trastuzumab deruxtecan Therapeutic category code : 429 Other antitumor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients who start receiving ENHERTU for injection, during the registration period.

Exclusion criteria

Exclusion criteria: Patients with a previous history of hypersensitivity to the ingredients of ENHURTS

Design outcomes

Primary

Measure	Time frame
safety The development of ILD based on the results of adjudication by the external ILD adjudication committee	—

Secondary

Measure	Time frame
safety Treatment-related ILD as reported by the investigator	—

Countries

Japan

Contacts

Public ContactContact for GPSP

DAIICHI SANKYO Co.,Ltd.

contact_gpsp_jp@daiichisankyo.com+81-3-6225-1059

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026