ZEN-3694 + Pembrolizumab + Chemotherapy for Breast Cancer
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot take strong inhibitors or inducers of CYP3A4, Factor Xa inhibitors, or Factor IIa inhibitors. It's important to discuss your current medications with the study team to ensure there are no interactions.
Is the combination of ZEN-3694, Pembrolizumab, and nab-paclitaxel safe for humans?
Nab-paclitaxel, a component of the treatment, is generally considered safe and is approved for use in several cancers, including breast cancer, with known side effects. It was developed to avoid certain toxicities associated with older formulations. However, specific safety data for the combination with ZEN-3694 and Pembrolizumab is not provided in the available research.12345
What makes the drug combination of ZEN-3694, Pembrolizumab, and Nab-paclitaxel unique for breast cancer treatment?
Research Team
Ana C Garrido-Castro
Principal Investigator
Dana-Farber - Harvard Cancer Center LAO
Eligibility Criteria
This trial is for adults with advanced triple-negative breast cancer that's spread and can't be removed by surgery. Participants must have acceptable organ function, no severe prior reactions to similar drugs, and not be on certain medications that affect the study drugs. They should not have had recent chemotherapy or immunotherapy, and women of childbearing age must use contraception.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Patients receive ZEN003694 orally once daily on days 1-21, nab-paclitaxel intravenously on days 1, 8, and 15, and pembrolizumab intravenously every 21 days of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Dose Expansion
Patients receive ZEN003694 orally once daily on days 1-7 prior to combination therapy, then continue with ZEN003694, nab-paclitaxel, and pembrolizumab as in dose escalation. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs 30 days after the last dose and then every 6 months for up to 3 years or until death.
Treatment Details
Interventions
- Nab-paclitaxel (Antimicrotubule Agent)
- Pembrolizumab (Monoclonal Antibodies)
- ZEN-3694 (BET Bromodomain Inhibitor)
Nab-paclitaxel is already approved in Canada for the following indications:
- Metastatic breast cancer
- Non-small cell lung cancer
- Adenocarcinoma of the pancreas
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor