A Phase 2 Study of Lapatinib in Combination With Trastuzumab in Patients With HER2-Positive, Metastatic Breast Cancer
- Participants will be asked to undergo a biopsy of an area of the body where the cancer
- Participants will be given a study medication-dosing calendar for each treatment cycle.
Each treatment cycle lasts four weeks during which time you will be taking lapatinib,
once per day.
- Participants will receive Herceptin once every week or once every 3 weeks through a
- During all treatment cycles a physical exam will be performed and questions about the
participants general health will be asked. Blood tests including chemistry and
hematology will be performed to measure additional effect of the study drug and disease
status. Photographs may be taken of the tumor to assess the response of the tumor to
- CT scans will be repeated every 8 weeks to assess the effect of the study treatment on
the cancer. Either a MUGA scan or echocardiogram will be performed 8 weeks and 16 weeks
after the participant starts the study treatment.
- Participants will remain on this research study for as long as they are benefiting from
the study treatment.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the rate of objective response by RECIST to combination therapy with lapatinib and trastuzumab, in the first-line and second/third line settings.
Nancy Lin, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Baylor College of Medicine||Houston, Texas 77030|
|Mayo Clinic||Rochester, Minnesota 55905|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Vanderbilt University||Nashville, Tennessee 37232-6305|
|University of North Carolina||Chapel Hill, North Carolina 27599|
|University of Chicago||Chicago, Illinois 60637|
|University fo Alabama at Birmingham||Birmingham, Alabama 35294|
|Dana-Farber at Faulkner Hospital||Boston, Massachusetts 02130|