Primary breast cancer T1-3 N0-1 M0 Histologically-confirmed HER 2 positive MedDRA version: 6.1 Level: PT Classification code 10006187
Conditions
Interventions
Product Name: lapatinib
Product Code: GW572016
Pharmaceutical Form: Tablet
Current Sponsor code: GW572016
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharm
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written and signed informed consent; 2. Female, aged 18 years or older; 3. Primary breast cancer T1-3 N0-1 M0 4. Histologically-confirmed HER 2 positive ErbB-2 3 , regardless of the FISH results, or 2 with FISH positive . 5. Bone marrow, renal, and hepatic function must meet the following criteria WBC 8805; 3.0 x 109/L Granulocyte count 1.500 x 109/L Platelet count 100 x 109/L Serum creatinine 120 mmol/L 1.35 mg/dl Serum bilirubin within normal/reference range AST/ALT within 1.5 x upper normal limit 6. Cardiac ejection fraction within the institutional range of normal as measured by echocardiography or MUGA. 7. Performance status 0 SWOG . 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous treatment for breast cancer including chemotherapy and endocrine therapy. 2. Known severe hypersensitivity to GW572016 or any of the excipients of this product; 3. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ. 4. As judged by the investigator, any evidence of severe or uncontrolled systemic disease e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease that would prevent subjects from undergoing any of the treatment options or would prevent prolonged follow-up. 5. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study. 6. Pregnancy or breast feeding women of child-bearing potential must have a negative pregnancy test within 7 days before the start of study treatment and practice acceptable methods of birth control to prevent pregnancy. . 7. Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment. 8. Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease e.g., Crohn s, ulcerative colitis .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to estimate the effect of GW572016 compared with placebo on the change in tumour cell proliferation in breast cancer tissue at baseline by core biopsy and after 3 or 9 weeks on the surgical specimen.;Secondary Objective: percentage of pCR; objective response rate; percent change in Epidermal growth factor receptor EGFR or HER-1 and HER-2; apoptosis ; additional markers of cell activation status; plasma concentrations of GW572016; incidence and severity of adverse event;Primary end point(s): percent change of Ki-67 | — |
Countries
Italy
Outcome results
None listed