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ZEN-3694 + Pembrolizumab + Chemotherapy for Breast Cancer
Study Summary
This trialtests a combo of drugs to treat advanced triple-negative breast cancer: chemo, immunotherapy and a drug to stop tumor cell growth.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am willing and able to have tumor biopsies before and during treatment.My kidney function is within the normal range.I had hepatitis C but have been successfully treated and cured.I have a digestive condition that affects how my body absorbs pills.I have never taken the study drug or any experimental BET inhibitors.I am currently taking blood thinners that target Factor Xa or IIa.I have had or currently have lung inflammation treated with steroids.My heart condition allows me to perform daily activities with slight limitations.I have active tuberculosis.I have not received a live vaccine in the last 30 days.I have not had bone-targeted radionuclide therapy in the last 6 weeks.My cancer can be measured or evaluated using specific criteria.My tests clearly show that my cancer has spread.My bilirubin levels are within the normal range, or slightly higher if I have Gilbert's Syndrome.My cancer does not express PD-L1.I have had 0 or 1 treatments for cancer that has spread.I am 18 years old or older.My blood clotting time is normal or slightly above, unless I'm on blood thinners.I agree to use effective birth control during the study.I can swallow and keep down pills.I have someone legally authorized to make decisions for me if I'm unable to.I have another cancer that won't affect this treatment's safety or results.My nerve damage does not significantly affect my daily activities.I can take care of myself but might not be able to do heavy physical work.I have recovered from serious side effects of previous cancer treatments.My breast cancer is triple-negative, not responding to hormones or HER2 treatments.I do not have any uncontrolled illnesses.I have had brain metastases but they have been treated.I haven't taken any tyrosine kinase inhibitors or small molecules recently.I have not had radiotherapy in the last week.My chronic HBV is undetectable with treatment.I have had multiple treatments for my cancer after it spread.I have previously been treated with immune checkpoint inhibitors or taxane-based therapy for advanced cancer.My cancer cannot be removed by surgery and has spread.My blood clotting time is normal or near normal, unless I'm on blood thinners.I don't need to know my PD-L1 status to join the dose escalation study.I am not taking strong CYP3A4 inhibitors or inducers.I am HIV-positive, on treatment, and my viral load is undetectable.I have an immune system disorder or have taken steroids in the past week.I haven't had chemotherapy, immunotherapy, major surgery, or experimental treatments in the last 3 weeks.I haven't had a heart attack or unstable chest pain in the last 6 months.
- Group 1: Dose Escalation (ZEN003694, nab-paclitaxel, pembrolizumab)
- Group 2: Dose Expansion (ZEN003694, nab-paclitaxel, pembrolizumab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the cohort size of this trial?
"Affirmative. Based on information hosted by clinicaltrials.gov, this experiment is still enrolling participants even though it was initially posted on September 30th 2022 and most recently edited 14 days ago. The trial aims to find 45 individuals from a single location for the study."
Could you advise if there are any available enrollments for participants?
"As clinicaltrials.gov confirms, this medical research is still enrolling participants and was originally posted on September 30th 2022 before being modified most recently on October 14th 2022."
What results does the research team anticipate from this endeavor?
"This trial's primary measure of success will be the incidence of adverse events over a 28 day period. Secondary endpoints include Time to Objective Response (TTOR) evaluated by RECIST 1.1 criteria, Overall Survival evaluations also following RECIST guidelines, and an assessment of Overall response rate (ORR)."
Has the Dose Escalation regimen of ZEN003694, nab-paclitaxel and pembrolizumab been authorized by the FDA?
"Due to its Phase 1 status, our team at Power has determined that the safety of Dose Escalation (ZEN003694, nab-paclitaxel, pembrolizumab) is likely low and rated it a score of 1."
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