GlaxoSmithKline Study EGF100161 – An open-label, multicenter, 2 Part, Phase I/II dose escalation study of oral lapatinib in combination with docetaxel (Taxotere) plus trastuzumab (Herceptin) in subjects previously untreated for ErbB2-overexpressing metastatic breast cancer.
- Conditions
- Metastatic Breast Cancer
- Registration Number
- EUCTR2005-000846-35-IE
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 179
Subjects >=18 years
Non-child bearing potential, or if of child-bearing potential then with negative serum pregnancy test at screening and agreement to follow protocol-defined methods of birth control
ECOG performance status of 0 or 1
Histologically or cytologically-confirmed invasive breast cancer
Measureable lesion according to RECIST
ErbB2 over-expression confirmed by central laboratory
Subjects with stable CNS metastases or leptomeningeal involvement are eligible only if they are not taking steroids or enzyme-inducing anticonvulsants
Prior radiotherapy must have been completed at least 4 weeks before enrollment
New or archived tumour tissue to be available prior to study entry to evaluate biomarkers
Adequate haematological, hepatic and renal function
Prior taxane therapy as part of adjuvant or neoadjuvant therapy is permitted as long as progression of disease occured more than 6 months after completion of therapy
Prior ErbB2 inhibitors in the adjuvant setting permitted, but disease-free interval of at least 12 months must be demonstrated after therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Peripheral neuropathy grade 2 or higher
Prior systemic therapy for locally advanced or metastatic disease or locul recurrence.
Prior chemotherapy in the adjuvant or neoadjuvant setting with anthracycline or anthracenedione-containing regimenswith doses > than those specified in the protocol
Prior systemic investigational drugs within the past 30 days or topical investigational drugs within the past 7 days
Subjects with uncontrolled or symptomatic angina, arrhythmias or congestive heart failure
Subjects with a known immediate or delayed hypersensitivity or untowards reaction to dectaxel, trastuzumab or other related compounds, or drugs related to lapatinib
Subjects taking any prohibited medications
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method