National Cancer Institute (NCI)
This phase Ib trial tests the safety and tolerability of ZEN003694 in combination with an immunotherapy drug called pembrolizumab and the usual chemotherapy approach with nab-paclitaxel for the treatment of patients with triple negative-negative breast cancer that has spread to other parts of the body (advanced). Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Immunotherapy with monoclonal antibodies, such as pembrolizumab may help the body's immune system attach the cancer and may interfere with the ability of tumor cells to grow and spread. ZEN003694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that over produce BET protein. Combination therapy with ZEN003694 pembrolizumab immunotherapy and nab-paclitaxel chemotherapy may help shrink or stabilize cancer for longer than chemotherapy alone.
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of BET bromodomain inhibitor ZEN-3694 (ZEN003694) used in combination with pembrolizumab and nab-paclitaxel in patients with locally advanced or metastatic triple negative-negative breast cancer (TNBC). II. Evaluate the safety and tolerability of ZEN003694 used in combination with pembrolizumab and nab-paclitaxel in patients with locally advanced or metastatic TNBC. SECONDARY OBJECTIVES: I. To observe and record anti-tumor activity. II. Confirm the recommended phase 2 dose (RP2D) from the…
Inclusion Criteria: * Participants must have a histologically or cytologically confirmed diagnosis of TNBC based on standard criteria for the disease: * Estrogen receptor (ER) and progesterone receptor (PR) \< 10% by immunohistochemistry (IHC), and HER2-negative (per current American Society of Clinical Oncology \[ASCO\]/College of American Pathologists \[CAP\] guidelines) * If there is more than one histological result available, the most recent sample with ER, PR and HER2 results will be considered for inclusion * Patients who have not had ER, PR and HER2 testing and thus, ER, PR and…
Given PO
Undergo biopsy
Undergo collection of blood samples
Undergo CT
Undergo MRI
Given IV
Given IV