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Phase II Randomized Study of Whole Brain Radiotherapy/Stereotactic Radiosurgery in Combination with Concurrent Lapatinib in Patients with Brain Metastasis from HER2-Positive Breast Cancer-A Collaborative Study of NRG Oncology and KrogPha
The purpose of this study is to compare the effects of adding lapatinib to
standard whole brain radiation therapy (WBRT) on cancer. The study will try to
find out whether WBRT or lapatinib plus WBRT is better at safely improving tumor control. In this study, you will receive either lapatinib plus WBRT or WBRT
You may or may not receive the investigational drug Lapatinib depending on
which treatment group you are placed in. The word "investigational" means that
the drug is being tested and is not approved by the FDA. Lapatinib is a drug that
has been approved by the FDA for patients with progressive HER2-positive
metastatic breast cancer. However, the combination of brain radiation and
lapatinib for the treatment of brain metastases is experimental. The combination
is being tested because lapatinib was found to improve the effectiveness of
radiation therapy in the laboratory. An early study in patients showed that brain
radiation and lapatinib can be combined safely.
You will be "randomized" into one of the study groups described below.
Randomization means that you are put into a group by chance. A computer
program will place you in one of the study groups. Neither you nor your doctor
can choose the group you will be in. You will have an equal chance of being
placed in any group.
If you are in Arm A: You will receive WBRT alone. You will receive radiation
therapy once a day, 5 days a week (Monday to Friday) for 3 weeks, for a total of
If you are in Arm B: You will receive WBRT plus lapatinib. You will receive WBRT
as in Arm A. In addition, you will begin taking oral lapatinib while you are receiving WBRT. You will take lapatinib once daily starting on the first day of
WBRT and continue throughout WBRT without drug holiday, including
Saturdays and Sundays. You will continue to take lapatinib for 3 weeks after you
have finished WBRT. Click here for more info
Patients must have proven diagnosis of invasive breast cancer with HER2 overexpression and brain metastases.
Patients must not have had prior whole brain radiation therapy.
Patients must not have had prior lapatinib therapy.
Applicable Disease Sites
Brain/Central Nervous System; Breast
Lapatinib; Tykerb (Lapatinib)
Johnson Creek, UW Cancer Center; UW Hospital and Clinics; UWCCC 1 South Park