A Randomized Multicenter Phase II Neoadjuvant Trial of Lapatinib Plus Trastuzumab, with or without Endocrine Therapy for 12 weeks vs. 24 weeks in patients with HER2 Overexpressing Breast Cancer
The purpose of this research study is to find out if it is better to give pre-surgery treatment with lapatinib and trastuzumab for 12 or for 24 weeks. Trastuzumab (Herceptin) is a laboratory-produced agent that is designed to target and block the function of HER2. Herceptin is approved for the treatment of HER2 positive breast cancer and is used prior to surgery in some circumstances. Lapatinib is a drug that is approved by the FDA for use in metastatic breast cancers when used with another drug called capecitabine. However, it is not approved for patients who have not yet received any treatment for their breast cancer. Therefore, its use in this setting (newly diagnosed breast cancer before surgery) is experimental. Patients who have hormone receptor positive disease will also receive endocrine therapy while on this study.
- Patients who have HER2 positive breast cancer - Patients who have not yet had surgery or any other treatment for their breast cancer Certain medications, prescribed for a variety of conditions, cannot be taken while receiving lapatinib. The study staff will review your medication list to make sure you arenâ??t taking any of the prohibited medications.
Before starting the study you will sign a consent form and undergo baseline testing. This testing will include lab work, EKG, chest x-ray, heart function tests, mammograms, breast ultrasound and breast biopsy. If these tests show that you are eligible you will also receive trastuzumab every 3 weeks along with Lapatinib orally every day for either 12 or 24 weeks. The trastuzumab is administered through a vein in your arm or chest in the clinic. In addition, if your tumor is estrogen or progesterone receptor positive (ER / PR positive), you will receive treatment with letrozole which is an aromatase inhibitor. If you are premenopausal (still having periods), you will also need a monthly injection of a medication to suppress your ovaries in addition to the letrozole. Your tumorâ??s response will be evaluated by clinical exam after 3, 6, 9, 12, 15, 18 and 21 weeks of treatment; study biopsies will be repeated once or twice during this period. The cost of the study drug (Lapatinib), and the research blood samples and tumor biopsies will be covered by the study. You and/or your health insurer will be responsible for all other procedures, tests, or drugs that are part of this study. You will be given information that details financial responsibility for each of the specific study requirements.
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