MALIGNANT NEOPLASM FEMALE BREAST MedDRA version: 6.1 Level: PT Classification code 10057654
Conditions
Interventions
Trade Name: HERCEPTIN*IV 1 FL 150 MG
Product Name: LAPATINIB
Product Code: GW572016
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: GW572016
Concentration unit: mg milligram(s)
Concentra
Sponsors
GLAXO SMITH KLINE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -histologically confirmed infiltrating primary breast cancer of 2.0 cm in largest clinical diameter -HER2 positive tumor either IHC 3 or FISH -Availability of tumor tissue suitable for biological and molecular examination before starting primary treatment -Age 18, 65 years -ECOG PS 0-1 -Normal organ and marrow function as defined below leukocytes 61619; 3000/ 61549;L absolute neutrophil count 61619; 61472;1,500/ 61549;L platelets 61619; 61472;100,000/ 61549;L total bilirubin within normal institutional limits AST SGOT /ALT SGPT 2.5 X institutional upper limit of normal Creatinine within normal institutional limits -Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan -Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of lapatinib will be determined following review of their use by the Principal Investigator. A list of medications and substances known or with the potential to interact with CYP450 isoenzymes is provided in Section 3.7.4.2 Other concomitant treatments -The effects of lapatinib on the developing human fetus at the recommended therapeutic dose are unknown; women of child-bearing potential must agree to use adequate contraception hormonal or barrier method of birth control or abstinence prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately, the patient should be apprised of the potential hazard to the fetus and potential risk for loss of the pregnancy -Ability to understand and the willingness to sign a written informed consent document -Ability to swallow and retain oral medication 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: -Stage IIIB, IIIC, and inflammatory breast cancer -Stage IV breast cancer -Contraindication to the treatment with anthracycline, paclitaxel and/or trastuzumab -Prior treatment with chemotherapy, endocrine therapy or radiotherapy. Prior treatment with EGFR targeting therapies -Treatment with any other investigational agents, or with all herbal alternative medicines -History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib -Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements -Pregnancy or breastfeeding; breast feeding should be discontinued to be enrolled in the study -Women of childbearing potential that refusal to adopt adequate contraceptive measures -HIV-positive patients receiving combination anti-retroviral therapy -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 -Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors See section 3.7.4.2 Other concomitant treatments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the percentage of pathological complete responses pCR in the breast and in the lymph nodes;Secondary Objective: -To estimate the percentage of clinical objective responses cOR complete plus partial, measured by USG in the breast -To estimate the percentage of breast conservative surgery -To evaluate the safety profile of the different combinations of chemotherapy and trastuzumab, lapatinib or both -To evaluate the percentage of inhibition of intermediate and final biomarkers of the proliferative and the apoptosis pathways induced by the different combinations of chemotherapy and trastuzumab, lapatinib or both. -To evaluate the correlation between tumor gene expression at diagnosis and pathological response in the three treatment arms.;Primary end point(s): -To estimate the percentage of pathological complete responses pCR in the breast and axillary nodes | — |
Countries
Germany, Italy, United Kingdom
Outcome results
None listed