A Phase II Study of XL184 (Cabozantinib) for Metastatic Triple-Negative Breast Cancer
In order to determine if you are eligible to participate in this study you will need to
undergo some tests and procedures. Many of these tests and procedures are likely to be part
of regular cancer care and may be done even if it turns out that you do not take part in the
research study. If you have had some of these tests and procedures recently, they may or may
not have to be repeated. These tests and procedures include a medical history, physical
exam, performance status, assessment of your tumor, blood tests, a urine test and a
pregnancy test (if applicable). If these tests show that you are eligible to participate in
the research study, you will begin the study treatment. If you do not meet the eligibility
criteria, you will not be able to participate in this research study.
If you take part in this research study, you will be given a one month supply of XL184 and a
study drug-dosing calendar for each treatment cycle. Each treatment cycle lasts 3 weeks
during which time you will be taking the study drug once per day by mouth.
During all cycles you will have a physical exam and you will be asked questions about your
general health and specific questions about any problems that you might be having and any
medications you may be taking.
The investigators will assess your tumor by CT scan or MRI after 6 weeks of treatment, and
then every nine weeks you remain on treatment.
The investigators will try to obtain samples of your tumor tissue from a biopsy if you have
had one previously. A new biopsy is optional, but may provide researchers with additional
information about how XL184 affects the tumor cells.
Participants will receive a pain questionnaire along with information on how to fill in the
The investigators would like to keep track of your medical condition for the rest of your
life. The investigators would like to do this by calling you on the telephone once every 6
months to see how you are doing. Keeping in touch with you and checking your condition every
year helps us look at the long-term effects of the research study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluation of XL184 based on objective response rate
To evaluate the activity of XL184, as defined by objective response rate (ORR) in patients with triple-negative metastatic breast cancer
Sara Tolaney, MD, MPH
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Dana-Farber Cancer Institute at Faulkner Hospital||Boston, Massachusetts 02215|