Study of Lapatinib in Breast Cancer Patients With HER-2 Non-amplified Primary Tumors and HER-2 Positive or EGFR Positive Circulating Tumor Cells

Launched by GLAXOSMITHKLINE · Jan 8, 2009

Keywords

ClinConnect Summary

Rationale: Despite recent progress in gene-expression profiling studies, the underlying biology of the various patterns of metastasis observed in different tumour types remains unclear. The detection and characterization of circulating tumour cells in cancer patients has provided important new information about the progression of metastatic events. This information has important implications for cancer prognosis and therapy.

This open label, multicenter phase II study is designed to evaluate overall tumour response rate in advanced breast cancer patients with HER-2 non amplified primary tu...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female patients at least 18 years old with HER-2 negative breast cancer.
• • Patients must have evidence of HER-2 or EGFR positive circulating tumour cells in a peripheral blood sample taken at screening visit.
• • Patients must have measurable, metastatic disease and no brain metastasis requiring local therapy.
• • Other criteria include ECOG score 0 to 2, life expectancy \> 12 weeks, baseline organ function at screening visit,
• • Previous treatment with anthracyclines and/or taxanes in the neo-adjuvant, adjuvant or advanced setting, and at least one line of treatment for metastatic disease.
• Exclusion Criteria:
• • Unstable medical conditions, pregnant or lactating women.
• • Inability to provide informed consent.
• • Lack of physical integrity of the upper gastrointestinal (GI) tract.
• • Co-existing malignancy or malignancies within the last 5 years with the exception of basal cell carcinoma or in-situ carcinoma, concurrent anti-cancer therapies (chemo or hormonal therapy) or investigational drugs other than study drug.
• • Concurrent radiotherapy to the only target lesion or concurrent bisphosphonates if bone metastases are the only target lesions.
• • Previous treatment with anti HER-2 or anti-EGFR therapies.
• • Protocol specified treatment regimens that would be inappropriate for the management of the subject.