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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

Phase 4
18 Years
Open (Enrolling)
Neoplasms, Breast

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Trial Information

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

Inclusion 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To offer pre-approval drug access to lapatinib, in combination with capecitabine, in order to provide potential clinical benefit to patients with ErbB2 overexpressing breast cancer.

Outcome Time Frame:

81 months

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:




Start Date:

July 2006

Completion Date:

June 2013

Related Keywords:

  • Neoplasms, Breast
  • advanced
  • HER2 positive
  • Stage IIIc
  • ErbB2 positive
  • GW572016
  • metastatic
  • Stage IIIb
  • breast cancer
  • Breast Neoplasms
  • Neoplasms