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ZEN003694 + Pembrolizumab + Nab-Paclitaxel for Advanced Triple-Negative Breast Cancer
This trialtests a combo of drugs to treat advanced triple-negative breast cancer: chemo, immunotherapy and a drug to stop tumor cell growth.
- Metastatic Triple-Negative Breast Cancer
- Breast Cancer
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Awards & Highlights
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Who is running the clinical trial?
- You have had allergic reactions to drugs that are similar to ZEN003694 (ZEN-3694), nab-paclitaxel, or pembrolizumab.You have received taxane-based therapy before to treat metastatic cancer.You may be eligible even if you have cancer that has spread to your brain or the tissues lining your brain and spine (leptomeningeal disease) as long as your doctor believes that you do not need immediate treatment for it and it is unlikely to become a problem during the first cycle of therapy.You have had or currently have another type of cancer that won't affect the evaluation of the new treatment.You had a heart attack or unstable chest pain in the last 6 months before starting the study drug ZEN003694 (ZEN-3694).If you haven't had a biopsy to confirm your cancer has spread, you must have clear signs of metastasis from a physical exam or radiology test.You do not need to know your PD-L1 status before joining the study's dose escalation group.You have already been treated with ZEN003694 (ZEN-3694) or another experimental medication that targets the same proteins.You have previously received drugs that affect the immune system for treating cancer that has spread.You have a disease that has spread to other parts of your body and cannot be removed by surgery.You can participate if you have been treated for metastatic cancer before.If you have had cancer that spread to your brain before but it was treated, you can participate if your cancer is still present outside of your brain and you have recovered from any side effects of previous treatments.If you have had side effects from previous cancer treatment, those side effects must have mostly gone away before you can participate in this trial. However, if you have hair loss (alopecia) from previous treatment, that doesn't matter.It is not known if ZEN003694 (ZEN-3694) and MK-3475 can harm an unborn baby.
- 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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