[Jackie07]

Protocol No.VICCBRE0779

Principal InvestigatorMayer, Ingrid
Phase
Phase II
Age Group Adult
Scope Local Secondary Protocol
No.8LAP109691

Title A Phase II Trial of Lapatinib and Trastuzumab with or without Endocrine Therapy in Locally Advanced HER2 Overexpressing Breast Cancer Patients (SPORE)

Objective To determine the pathologic response to neoadjuvant lapatinib with trastuzumab

Description Women are being asked to take part in this research study because they have a type of breast cancer that contains the HER-2/neu protein (HER-2/neu positive).

The purpose of this study is to determine if Lapatinib (Tykerb®) and Trastuzumab (Herceptin®) used together for 12 weeks can shrink HER-2/neu positive breast cancer tumors before surgery. If so, this may allow for a lumpectomy instead of a mastectomy. A lumpectomy removes the entire tumor without removing the whole breast. A mastectomy removes the whole breast with the tumor.

Several clinical studies show that lapatinib attacks breast cancer cells that have two proteins called EGFR and HER-2/neu. These proteins are important for the growth and survival of breast cancer cells that make these proteins. Lapatinib is approved by the Food and Drug Administration (FDA) for the treatment of advanced (metastatic) breast cancers with the HER-2/neu protein that have stopped responding to trastuzumab. The FDA has already approved trastuzumab, which is standard of care treatment for both early and advanced forms of HER-2/neu positive breast cancer. Some breast cancers also need the female hormone estrogen to grow. Patients with these hormone positive cancers will also take a drug called Letrozole (Femara®). Letrozole is FDA approved as a standard treatment for post-menopausal women with hormone-positive breast cancers for both early and advanced forms of breast cancer. Letrozole slows or stops the growth of cancer cells by decreasing the amount of estrogen produced in the body.

Up to 64 women will be enrolled in this study. Lapatinib will be administered at 1,000 mg daily together with a standard weekly dose of trastuzumb. Bidimensional tumor measurements will be performed at baseline, and at the end of week 4 and week 8. At week 8, breast ultrasound measurements will be performed to ensure no disease progression. At any time, the patient will be taken off study protocol and offered standard therapy if there is any clinical or imaging evidence of disease progression. At the end of the 12 weeks, further treatment will depend on the treating physician. Repeat mammograms and breast ultrasounds will be performed. The patient will be offered surgery if operable and a surgical specimen will be obtained. If the patient is not operable and desires breast conserving surgery, an additional biopsy will be obtained. She could then continue on chemotherapy with trastuzumab and weekly paclitaxel for an additional 12 weeks, as a standard of care regimen. She will be offered surgery at the completion of her chemotherapy with surgical specimen collection at this time. Further treatment will be at the discretion of the treating physician.