Clinical Evaluation of Lapatinib Administered with Capecitabine in Japanese Patients with ErbB2 Overexpressing Advanced or Metastatic Breast Cancer
Phase 1
- Conditions
- ErbB2 Overexpressing Advanced or Metastatic Breast Cancer
- Registration Number
- JPRN-jRCT2080220386
- Lead Sponsor
- GlaxoSmithKline K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
- Signed informed consent
- ErbB2 overexpressing advanced or metastatic breast cancer
- Prior treatments with taxanes, anthracyclines, trastuzumab
- No prior treatment with capecitabine
- Female 20 years of age
- ECOG Performance Status of 0 or 1
- Cardiac ejection fraction within the institutional range of normal
- Adequate hematologic value, hepatic and renal function
- Pregnant or lactating females
- Conditions affecting the absorption of oral drugs
- History of other malignancy
- Known history of uncontrolled or symptomatic angina, arrhythmia or congestive heart failure
- Known history or clinical evidence of leptomeningeal carcinomatosis
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method