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Protocol No. RTOG1119

Principal Investigator Anderson, Bethany

Phase II

Age Group Adult

Scope National

Sponsor Type National

Title 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

Objective 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 alone.

Treatment 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.

Description 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 15 treatments. 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

Key Eligibility
  • 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

    Therapies Involved Other; Radiotherapy

    Drugs Involved Lapatinib; Tykerb (Lapatinib)

    Status Open

    Participating Institutions Johnson Creek, UW Cancer Center; UW Hospital and Clinics; UWCCC 1 South Park