Clinical Trial NU 12B06
- A Pilot Phase II Trial of Cabergoline in the Treatment of Metastatic Breast Cancer
- Principal Investigator
- Cesar Santa-Maria
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.NU 12B06
- The purpose of this study is to evaluate the effectiveness of cabergoline in treating metastatic breast cancer disease in those who test positive for the prolactin receptor.
- Prolactin is a hormone produced in the pituitary gland. Previous studies have revealed that elevated levels of the hormone prolactin might be associated with an increased risk of breast cancer. Cabergoline is approved by the Food and Drug Administration (FDA) for the treatment of hyperprolactinemic disorders (elevated levels of prolactin in the blood). Cabergoline has been shown to lower prolactin levels in the blood. Cabergoline is not FDA approved for use in metastatic breast cancer, it is being used as an investigational drug in this study.
Some of the eligibility criteria include:
- Participants must be at least 18 years of age or older.
- Participants must have metastatic breast cancer (it has spread beyond the breast).
- Participants must have tumors (primary or metastatic) that stain positively for the prolactin receptors.
- Description of Treatment
- Participants will take cabergoline by mouth twice a week for a period of 4 weeks. This 4 week period is called a cycle. Participants will be evaluated for side effects and to measure prolactin levels in the blood approximately every 4 weeks, prior to starting the next cycle of treatment. Participants will have their breast cancer evaluated approximately every 8 weeks (after every 2 cycles) to see whether it is responding to the treatments. Participants will continue to receive treatment until their disease progresses or it is determined that it is in their best interest to discontinue the study drug.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 09-Feb-16 04:31 PM
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