This study is looking to trial the addition of a new form of vaccine called a neoantigen vaccine in combination with nab-paclitaxel (Abraxane), duvalumab (Imfinzi), and tremelimumab (CP-675,206), in patients with metastatic triple-negative breast cancer (mTNBC). The main outcome that will be measured is survival without the cancer progressing. This trial is carried out in Connecticut, United States.
The details
Breast cancer is one of the most common cancers worldwide. TNBC accounts for about 10-15% of all breast cancers. TNBC does not have estrogen or progesterone receptors, or elevated levels of the HER2 protein. This can make TNBC difficult to treat.
Nab-paclitaxel is a chemotherapy medication. Durvalumab and tremelimumab, are immunotherapies. Neoantigen vaccines may help the body build an effective immune response to kill tumor cells. It is not yet known whether the combination of the drugs is effective in TNBC that has spread.
This trial is evaluating the effectiveness and safety of nab-paclitaxel,durvalumab, and tremelimumab with or without a neoantigen vaccine in patients with mTNBC. The main outcome to be measured is survival without the spread of the cancer.
Who are they looking for?
This trial is looking to recruit 70 patients with mTNBC. Patietns must no previous therapy for mTNBC, adequate blood cell counts, and adequate liver, kidney, and heart function. Women of childbearing potential must agree to use effective birth control during the study and 180 days after the last dose of durvalumab.
Patients will be excluded from this trial if they have recieved chemotherapy, radiotherapy, or biologic therapy within the past 30 days, patients who have had a major surgery within 30 days of starting this trial, and any uncontrolled illnesses. Patients who have received a live vaccine in the previous 6 months will also be excluded.
How will it work
There are two groups in this trial. Both groups will receive chemotherapy with gemcitabine (Gemzar) and carboplatin (Paraplatin) for 6 cycles. One group will also receive the neoantigen vaccine, durvalumab, tremelimumab, and nab-paclitaxel. The second group will also receive durvalumab, tremelimumab and nab-paclitaxel.
Patients will be evaluated up to 12 months. The main outcomes evaluated will be survival without cancer progression, the occurrence of side effects, the response rate, and overall survival.
