Protocol Title

An open-label, multi-centre study of lapatinib in combination with chemotherapy in patients with ErbB2 overexpressing breast cancer after trastuzumab failure in the neoadjuvant or adjuvant setting (438-07)

Description

ErbB2 is one member of a family of genes that provides instructions for producing proteins that stimulate cell growth and division. Patients with ErbB2 overexpressing breast cancer that has progressed during or within 6 months after completing treatment that included trastuzumab (Herceptin) for treatment of newly diagnosed breast cancer are likely resistant to trastuzumab. Preclinical data suggest that breast cancer that is resistant to trastuzumab may respond to treatment with lapatinib. Using lapatinib in combination with chemotherapy appears to be appropriate to study as combination therapy after being failed by trastuzumab.

The treatment in this study is lapatinib plus one of three chemotherapy drugs (capecitabine or docetaxel or nab paclitaxel). The chemotherapy to be used will be decided by the participant’s doctor.

Objectives

To evaluate overall tumor response rate of lapatinib given in combination with chemotherapy

To evaluate progression-free survival, time to and duration of response for subjects treated with this combination To evaluate the side effects of subjects treated with this combination

Eligibility

Patient is at least 18 years of age.

Patient has a histological diagnosis of metastatic breast cancer and has disease that can be measured on their imaging studies (CT scan, MRI, bone scan).

Patients of childbearing potential must have a negative pregnancy test and agree to use an accepted method of non-hormonal contraception

Patients must have breast cancer that overexpresses ErbB2 and have progressed during or within 6 months of treatment that included trastuzumab in the neoadjuvant or adjuvant setting.

Patient must have adequate organ function and meet other guidelines for eligibility as specified by the protocol.

Contact

For the current eligibility status of and additional information about this clinical study, please contact Breastlink Clinical Research Group at 1-562-981-6101.

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