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Study identifier: NCT05422794 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Testing the Addition of Anti-Cancer Drug, ZEN003694 (ZEN-3694) and PD-1 Inhibitor (Pembrolizumab), to Standard Chemotherapy (Nab-Paclitaxel) Treatment in Patients With Advanced Triple-Negative Breast Cancer

Condition: Anatomic Stage III Breast Cancer AJCC v8 · Anatomic Stage IV Breast Cancer AJCC v8 · Locally Advanced Triple-Negative Breast Carcinoma  ·  Sponsor: National Cancer Institute (NCI)

PhasePhase 1
Planned participants57
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

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Contact details are listed per location below or on the registry record.

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Locations (6)

Boston Medical CenterBoston, Massachusetts, United StatesRecruiting
Dana-Farber Cancer InstituteBoston, Massachusetts, United StatesRecruiting
NYU Langone Hospital - Long IslandMineola, New York, United StatesRecruiting
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew York, New York, United StatesRecruiting
Ohio State University Comprehensive Cancer CenterColumbus, Ohio, United StatesRecruiting
Vanderbilt Breast Center at One Hundred OaksNashville, Tennessee, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT05422794