Phase 1b study of U3-1287 in combination with trastuzumab plus paclitaxel in patients with HER2-positive metastatic breast cancer (MBC)
Phase 1
- Conditions
- HER2-positive MBC
- Registration Number
- JPRN-jRCT2080221730
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Female
- Target Recruitment
- 36
Inclusion Criteria
Histologically or cytologically confirmed invasive carcinoma of the breast with metastatic disease
- Documented HER2-positive disease
- ECOG performance status: 0 or 1
Exclusion Criteria
- Has history of anti-HER3 therapy
- Total dose of anthracyclines >= 360mg/m2 in prior treatment
- Patients with active other malignancies
- Has history or complication of interstitial lung disease by radiographic examination
- Left ventricular ejection fraction(LVEF) < 55% at enrollment or history of LVEF decline >= 10% from base line on prior trastuzumab therapy and the decline to <55%
- Has brain metastasis with clinical symptoms or requiring treatment
- Has history of serious drug hypersensitivity reaction such as anaphylaxis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and pharmacokinetics<br>NCI-CTC ver. 4.03
- Secondary Outcome Measures
Name Time Method - Incidence of anti-U3-1287 antibody<br>- Preliminary assessment of anti-tumor activity of U3-1287<br>- Exploratory study on U3-1287-related biomarker<br>RECIST ver. 1.1