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This study evaluates the combination of Lapatinib and Trastuzumab (Herceptin) in patients with HER2-positive metastatic breast cancer. It included patients with measurable disease and confirmed HER2-positivity. It was a Phase 2 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Histologically or cytologically confirmed invasive breast cancer, with stage IV disease * HER2-positive breast cancer, defined as 3+ staining by IHC or gene amplification by FISH * Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension * Willingness to undergo a research biopsy of recurrent or metastatic disease * Prior chemotherapy treatment must be discontinued for at least 2 weeks prior to study entry. * Completed radiation therapy at least 7 days prior to beginning protocol treatment * Cohort 1: No prior chemotherapy for advanced breast cancer; no prior trastuzumab in the advanced breast cancer setting; nor prior treatment with lapatinib or other HER2-directed therapy other than trastuzumab * Cohort 2: Up to two prior chemotherapy regimens for the treatment of advanced breast cancer; no prior treatment with lapatinib or other HER2-directed therapy except for trastuzumab * 18 years of age or older * Life expectancy of greater than 12 weeks * ECOG Performance Status 0-2 * Normal organ and marrow function as outlined in protocol * Cardiac ejection fraction, as assessed by either MUGA scan or echocardiogram greater than or equal to 50% * Able to take oral medications Exclusion Criteria: * Patients may not be receiving any other investigational agents or concurrent chemotherapy or hormonal therapy for treatment of metastatic disease * Active brain metastases * History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or other agents used in this study * Clinically significant malabsorption syndrome * Uncontrolled intercurrent illness * Pregnant or breastfeeding women * Concurrent use of the medications listed in the protocol because of possible interaction with lapatinib