Clinical Trial NU 15B08
- A Phase II Single Arm Study of Palbociclib in Patients with Metastatic HER2-positive Breast Cancer with Brain Metastasis
- Principal Investigator
- Cesar Santa-Maria
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.NU 15B08
- The purpose of this study is to evaluate if the study drug palbociclib has anti-tumor activity against the breast cancer that has spread to the brain. And to determine the overall radiographic response rate in the CNS.
- Palbociclib is an anti-cancer medication that has been shown to stop cancer cells from growing. It has been approved in hormone positive breast cancer, along with other hormone therapies and has been found to be effective. The preclinical studies suggest that the drug may also have activity in other types of breast cancer, such as triple negative and HER2 positive breast cancer. The study drug palbociclib is a small molecule and can penetrate the meninges. The purpose of this study is to see if the study drug is effective in patients with brain metastasis, who have triple negative and HER2-positive breast cancer.
Some of the eligibility criteria include:
- Participants who have been diagnosed with triple negative or HER2-positive metastatic breast cancer.
- Participants must have been treated previously with more than two lines of chemotherapy for metastatic disease.
- Participants must be 18 or older.
- Description of Treatment
- All study participants will get the study drug in the form of a pill that will be taken once a day for 21 days followed by a 7 day break. These 28 days is considered as one cycle. The participants with HER2-positive breast cancer may also receive trastuzumab (standard of care) concurrently.
- Clinical Trials Recruitment Nurse
Robert H. Lurie Comprehensive Cancer Center
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last updated: 17-Aug-17 04:46 AM
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