This study will provide pre-approval drug access to lapatinib, in combination withcapecitabine, to patients whose breast cancer had progressed on other therapies
Drug: lapatinib + capecitabine
Experimental
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
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London, United Kingdom
Novartis Investigative Site
London, United Kingdom
Novartis Investigative Site
London, United Kingdom
Novartis Investigative Site
London, United Kingdom
Novartis Investigative Site
Manchester, United Kingdom
Novartis Investigative Site
Nottingham, United Kingdom
Novartis Investigative Site
Peterborough, United Kingdom
Novartis Investigative Site
Poole, Dorset, United Kingdom
Novartis Investigative Site
Portsmouth, United Kingdom
Novartis Investigative Site
Shrewsbury, United Kingdom
Novartis Pharmaceuticals, Study Director
Novartis Pharmaceuticals