Metastatic Breast Cancer
Conditions
Interventions
Product Name: lapatinib
Product Code: GW572016
Pharmaceutical Form: Coated tablet
INN or Proposed INN: lapatanib
CAS Number: 388082-78-8
Current Sponsor code: GW572016
Concentration unit: mg milligram
Sponsors
GlaxoSmithKline
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part 1. To determine the Optimally Tolerated Regimen (OTR) of Lapatanib when administered with both docetaxel and trastuzumab. Part 2. To evaluate tumour response rate of lapatinib when administered together with docetaxel and trastuzumab compared to the response rate of the docetaxel and trastuzumab combination.;Secondary Objective: Part 1. To determine the clinical activity of Lapatanib when administered in combination with both docetaxel and trastuzumab. Part 2. To evaluate activity in terms of duration of response, time to response, time to progression (TTP), progression-free survival and overall survival;Primary end point(s): Part 1. The OTR for the triple combination will be defined as the dose level at which no more than one subject out of six experiences a dose-limiting toxicity (DLT) after completing one treatment cycle. Adverses events and changes from baseline in laboratory values will be evaluated to assess safety and tolerability. Part 2. The primary efficacy endpoint is objective tumour response rate as measured by radiological imaging, photography and /or physical exmaination performed every other cylce and recorded according to RECIST criteria. | — |
Countries
Ireland
Outcome results
None listed