Phase 1 Study to Evaluate the Effect of DS-8201a on the QT/QTc Interval in HER2-Expressing Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- JPRN-jRCT2080223735
- Lead Sponsor
- DAIICHI SANKYO Co.,Ltd.
- Brief Summary
This study characterized the PK profile of DS-8201a after multiple dosing and demonstrated that DS-8201a has no clinically meaningful impact on the QTc interval. Furthermore, the results of this study support a manageable safety profile and antitumor activity of DS-8201a in patients with HER2-expressing metastatic and/or unresectable BC.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 51
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.
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,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method