Pharmacokinetics/pharmacodynamics/genome pharmacology study of the antibody-drug conjugate Sacituzumab Govitecan: multi-institutional prospective observational trial

Pharmacokinetics/pharmacodynamics/genome pharmacology study of the antibody-drug conjugate Sacituzumab Govitecan: multi-institutional prospective observational trial - Pharmacokinetics/pharmacodynamics/genome pharmacology study of the antibody-drug conjugate Sacituzumab Govitecan: multi-institutional prospective observational trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000059286

Enrollment

100

Registered

2025-10-04

Start date

2026-05-01

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

Triple Negative Breast Cancer (TNBC)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with inoperable or recurrent TNBC. 2. Patients aged 18 years or older scheduled to undergo SG therapy. 3. Patients who have provided written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who are pregnant or may be pregnant 2. Patients taking UGT1A1-inducing drugs (carbamazepine, phenytoin, rifampicin, phenobarbital) 3. Patients who have withdrawn their consent 4. Other cases deemed unsuitable by the physician

Design outcomes

Primary

Measure	Time frame
Evaluation of the correlation between UGT1A1 gene polymorphism and the incidence of grade 3 or higher neutropenia.	—

Secondary

Measure	Time frame
Evaluation of the correlation between drug blood concentration and adverse event incidence rate.	—

Countries

Japan

Contacts

Public ContactHitoshi Kawazoe

Keio University Division of Clinical Pharmacy, Faculty of Pharmacy

kawazoe-ht@keio.jp03-5400-2486

Outcome results