Trial Information

Tolerability of the Combination of Lapatinib and Trastuzumab in Adults Age 60 or Older with HER2 Positive Locally Advanced or Metastatic Breast Cancer

You have been invited to participate in this research study because you have HER2 positive (HER2+) breast cancer that has spread to other parts of your body. To main purpose is to evaluate the safety and tolerability of combination treatment with trastuzumab and lapatinib in adults age 60 or older with metastatic breast cancer. Other objectives are to evaluate side effects, particularly gastrointestinal effects (diarrhea, nausea and vomiting), which are common in younger adults receiving this treatment, and effects on the heart. The study will explore factors other than age that affect side effects. A series of blood samples will be drawn for pharmacokinetic (PK) testing that shows how the body processes lapatinib over time. Response to treatment, clinical benefit, survival without disease progression, and overall survival will be evaluated. The study will also look at whether older adults take lapatinib at home as directed by their study doctor. Your treatment on this study is expected to last until the drug stops working, or until you are having so much trouble with side effects that we need to discontinue the drug. After your treatment on this study is over, you will continue to be followed for 30 days or until all your side effects have disappeared. After your treatment on this study is over, your medical condition will continue to be followed indefinitely.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

City of Hope
1500 East Duarte Road
Duarte, CA 91010-3000
Phone: 866-896-HOPE (4673)

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Research Center Information: City of Hope

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