EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer

Study Overview
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Brief Summary
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This study will provide pre-approval drug access to lapatinib, in combination with capecitabine, to patients whose breast cancer had progressed on other therapies

Official Title
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An Open-Label Expanded Access Study of Lapatinib and Capecitabine Therapy in Subjects With ErbB2 Overexpressing Locally Advanced or Metastatic Breast Cancer

Conditions
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Neoplasms, Breast

Intervention / Treatment
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* Drug: lapatinib + capecitabine


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: May have received prior lapatinib in another trial. Previous capecitabine (as previous agent or non-lapatinib containing regimen) is also permitted. Prior treatment with hormonal therapy is allowed. Must have advanced or metastatic breast cancer with progression (as assessed by modified RECIST) after prior therapy, which must include all of the following: prior treatment with an anthracycline, a taxane, and trastuzumab alone or in combination with other therapy. Trastuzumab must have been administered in the adjuvant, or locally advanced or metastatic setting. Must have tumors that overexpress ErbB2 defined as +3 by IHC or FISH positive for ErbB2 gene amplification. The status of ErbB2 expression must be documented prior to study entry. Must be >/= 18 years of age Life expectancy of > 8 weeks Must have recovered from side effects of previous treatment Patients with CNS mets are eligible provided treatment with prohibited medications as listed in the protocol are not required Cardiac ejection fraction must be within the institutional range of normal as measured by ECHO. MUGA scans are allowed if ECHOs cannot be performed Able to swallow and retain oral medications Must have adequate hematologic, hepatic and renal function Exclusion criteria: Pregnant or lactating females Malabsorption syndrome, disease significantly affecting GI function, or resection of the stomach or bowel, or ulcerative colitis Concurrent disease or condition that would make the patient inappropriate for study participation Unresolved or unstable toxicity from prior administration of another investigational drug and/or prior cancer treatment Uncontrolled infection Active cardiac disease defined as history of uncontrolled or symptomatic angina; history of arrhythmias requiring medication, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation; MI < 6 months from study entry; uncontrolled or symptomatic CHF; ejection fraction below the institutional normal limit; any other cardiac condition that would make this protocol unreasonably hazardous for the patient Receiving concurrent chemotherapy (other than capecitabine), radiation therapy, immunotherapy, biologic therapy or hormonal therapy for cancer. Concurrent therapy with bisphosphonates is allowed History of allergic reaction attributed to compounds of similar composition to lapatinib or any excipients History of allergic reactions attributed to compounds of similar chemical composition to capecitabine, fluorouracil or excipients Known DPD deficiency

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: lapatinib + capecitabine|Experimental|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced, TYKERB, HER2 positive, Stage IIIc, ErbB2 positive, GW572016, metastatic, Stage IIIb, breast cancer