Clinical Trial NU 16B08
- Phase II Study of Pembrolizumab and Capecitabine for Advanced Triple Negative and Hormone-Refractory Breast Cancer
- Principal Investigator
- William Gradishar
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.NU 16B08
- The purpose of this study is to see whether a combination of two different drugs – pembrolizumab and capecitabine – is safe, and if it might be effective in treating metastatic breast cancer.
- This is a phase II study in which we will enroll participants to gather more information on how useful and effective the combination of pembrolizumab and capecitibine is in the treatment of triple negative and hormone-refractory breast cancer. Pembrolizumab is a type of drug that contains an antibody. Antibodies are the part of your immune system that finds things that don’t belong in your body, such as bacteria or viruses. The antibody in pembrolizumab finds and blocks a protein, which allows your immune system to target and destroy cancer cells. Pembrolizumab is FDA approved for other types of cancer. It is not approved for breast cancer, meaning that it is an “experimental” or “investigational” treatment. Capecitabine is a type of chemotherapy pill that is a standard treatment and FDA-approved for breast cancer. It stops the cancer cells from being able to multiply.
Some of the eligibility criteria include:
- Participants must be age 18 years or older and may be male or female.
- Participants must have breast cancer that is either metastatic, can't be removed by surgery, or has spread widely in the area of the breast.
- Participants' breast cancer must be either triple-negative or hormone-positive (if hormone positive, the participant must have progressed on hormonal therapy to be eligible).
- Description of Treatment
- All participants enrolled on this study will receive pembrolizumab and capecitabine in 21 day periods called cycles. Pembrolizumab will be given through a vein on Day 1 of each cycle. Capecitabine will be given by mouth twice per day on days 1-14 of each cycle. Participants will continue to receive treatment until their disease gets worse or until they experience an unacceptable side effect. After stopping the study drugs, participants will be assessed every 3 months for up to 1 year with visits and/or phone calls.
- Clinical Trials Recruitment Nurse
Robert H. Lurie Comprehensive Cancer Center
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- A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients with HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment
- A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer
last updated: 17-Aug-17 04:44 AM
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