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

• Register: ClinicalTrials.gov
• Last refreshed on: 18 April 2016
• Main ID: NCT00338247
• Date of registration: 16/06/2006
• Prospective Registration: Yes
• Primary sponsor: Novartis
• Public title: EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer
• Scientific title: An Open-Label Expanded Access Study of Lapatinib and Capecitabine Therapy in Subjects With ErbB2 Overexpressing Locally Advanced or Metastatic Breast Cancer
• Date of first enrolment: July 2006
• Recruitment status: Approved for marketing
• URL: https://clinicaltrials.gov/show/NCT00338247
• Study type: Expanded Access
• Study design: N/A
• Phase: Phase 4

Countries of recruitment

Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Bulgaria, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hong Kong, Iceland, Indonesia, Ireland, Israel, Italy, Korea, Republic of, Latvia, Luxembourg, Malaysia, Malta, Mexico, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, United States, Venezuela

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Neoplasms, Breast

Intervention(s)

Drug: lapatinib + capecitabine

Secondary ID(s)

EGF103659

Source(s) of Monetary Support

Please refer to primary and secondary sponsors