Phase 1 Study to Evaluate the Effect of DS-8201a on the QT/QTc Interval in HER2-Expressing Breast Cancer

Phase 1, Multicenter, Open-Label, Multiple-Dose Study of DS-8201a to Assess the Effect on the QT Interval, and Pharmacokinetics in Subjects with HER2-Expressing Metastatic and/or Unresectable Breast Cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223735

Enrollment

Registered

2017-11-29

Start date

2017-12-26

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

Breast Cancer

Interventions

investigational material(s) Generic name etc : DS-8201a INN of investigational material : trastuzumab deruxtecan Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Inv

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Has a pathologically documented unresectable or metastatic breast cancer with HER2 expression (immunohistochemistry [IHC] 3+, IHC 2+, IHC 1+ and/or in situ hybridization [ISH]* +) that is refractory to or intolerable with standard treatment, or for which no standard treatment is available. 2. LVEF >= 50% . 3. Has an ECOG PS 0 or 1.

Exclusion criteria

Exclusion criteria: 1. Has a medical history of myocardial infarction within 6 months before enrollment. 2. Has a medical history of ventricular arrhythmias, other than rare, occasional premature ventricular contractions. 3. Has uncontrolled or significant cardiovascular disease,

Design outcomes

Primary

Measure	Time frame
pharmacokinetics other -To assess the effect of DS-8201a on the QTc interval -To assess PK after multiple dosing of DS-8201a Baseline-adjusted QTcF interval, serum concentration and PK parameters of DS-8201a, total anti-HER2 antibody, and MAAA-1181a.	—

Secondary

Measure	Time frame
safety efficacy -Concentration-QT, -Objective response rate (ORR) -Disease control rate (DCR) RECIST Version 1.1	—

Countries

Japan

Outcome results

None listed

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