Protocol Number: 05-C-0231

Title:

A Phase II Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of Lapatinib in Patients with Relapsed or Refractory Inflammatory Breast Cancer

Number:

05-C-0231

Summary:

Summary: This study will examine the safety and effectiveness of the experimental drug lapatinib in treating patients with inflammatory breast cancer. Inflammatory breast cancer is an aggressive form of locally advanced breast cancer that often causes a red, swollen, tender breast and is associated with a poor prognosis. Lapatinib has been shown to block receptors on breast cancer cells for chemicals that can cause the cancer cells to grow.

Patients with inflammatory breast cancer whose disease has not responded to prior chemotherapy (including at least one regimen containing doxorubicin or epirubicin) may be eligible for this study. Candidates are screened with a medical history, physical examination, electrocardiogram, echocardiogram, blood test, imaging studies (CT or MRI), photographs to document the extent of disease and a tumor biopsy (surgical removal of a small piece of tumor tissue) to look for the presence of certain proteins that control the way cells divide and stay alive.

Participants take six lapatinib tablets by mouth as a single dose every day in 28-day treatment cycles. Patients may continue treatment until they no longer benefit from it or until they or the study doctor decides to discontinue treatment for another reason. In addition, patients undergo the following procedures:

-Update changes in medical and medication history every 28 days

-Clinical examination and measurement of vital signs every 28 days

-Blood tests every 28 days

-Imaging studies (x-ray and possibly CT or MRI) every 8 weeks

-Echocardiogram or MUGA every 8 weeks

-Photograph every 28 days

-Repeat biopsy after 28 days to examine the effects of lapatinib on proteins produced by the tumor cells

These tests, with the exception of the biopsy, are repeated at the end of the study within 28 days after the last dose of study medication and before starting any other type of treatment for breast cancer.

In addition to the above procedures, patients may consent to the following additional procedures:

-Genetic research on tumor tissue to help understand what factors determine if the lapatinib will or will not work against the tumor (done by Glaxo-Smith Kline, the manufacturer of the drug)

-Research on blood sample to study genetic differences in how individuals respond to or handle lapatinib (done by Glaxo-Smith Kline)

-Laboratory research on blood and tumor samples to identify genes that are turned on in the setting of inflammatory breast cancer and identify the series of events that occur within cells causing breast cancer to present in this aggressive manner

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Tumor Growth Arrest

Tumor Cell Apoptosis

Receptor Tyrosine Kinase

ErbB Receptors

Molecular Targets

Recruitment Keyword(s):

Inflammatory Breast Cancer

IBC

Condition(s):

Inflammatory Breast Cancer

Breast Cancer

Investigational Drug(s):

None

Investigational Device(s):

None

Interventions:

Drug: Lapatinib

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Olayioye MA, Neve RM, Lane HA, Hynes NE. The ErbB signaling network: receptor heterodimerization in development and cancer EMBO J. 2000 Jul 3;19(13):3159-67.

Klapper LN, Kirschbaum MH, Sela M, Yarden Y. Biochemical and clinical implications of the ErbB/HER signaling network of growth factor receptors. Adv Cancer Res. 2000;77:25-79.

Charafe-Jauffret E, Tarpin C, Bardou VJ, Bertucci F, Ginestier C, Braud AC, Puig B, Geneix J, Hassoun J, Birnbaum D, Jacquemier J, Viens P. Immunophenotypic analysis of inflammatory breast cancers: identification of an 'inflammatory signature'. J Pathol. 2004 Mar;202(3):265-73.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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