Actively 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
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
57
Participants Needed
6
Research Sites
201 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed triple-negative breast cancer with ER and PR < 10% and HER2-negative
- Unresectable locally advanced or metastatic disease
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Karnofsky >= 60%)
- Adequate blood counts and organ function as specified
- Ability to swallow and retain oral medications
- Willingness to sign informed consent
- For dose expansion cohort: PD-L1 negative status, 0-1 prior systemic therapy lines in metastatic setting, measurable disease, and amenable to biopsy if safely accessible
- Patients with treated CNS metastases meeting specific recovery criteria
- HIV patients with undetectable viral load on stable therapy
- Patients with controlled hepatitis B or cured hepatitis C under specified conditions
- Patients with prior or concurrent malignancies not interfering with trial assessments
You will not qualify if you...
- Allergic reactions to ZEN003694, nab-paclitaxel, or pembrolizumab
- Uncontrolled illnesses
- Active autoimmune disease requiring systemic treatment in past 2 years
- Gastrointestinal disorders affecting oral drug absorption
- Pregnant or breastfeeding women
- Prior treatment with ZEN003694 or investigational BET inhibitors
- For dose expansion cohort: prior immune checkpoint inhibitors or taxane therapy in metastatic setting within specified timelines
- Use of strong CYP3A4 inhibitors or inducers without appropriate discontinuation
- Use of Factor Xa or Factor IIa inhibitors except for low molecular weight heparin
- Bone-targeted radionuclide therapy within 6 weeks
- Recent myocardial infarction or unstable angina
- Immunodeficiency or recent immunosuppressive therapy
- History of pneumonitis requiring steroids or current pneumonitis
- Active tuberculosis
- Live vaccine within 30 days prior to treatment
- Extensive bone marrow infiltration deemed clinically significant
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
4
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Actively Recruiting
5
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
6
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, United States, 37204
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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