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NCT05422794 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
- 6
- Study locations
NCT05422794: Recruiting Phase 1 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
NCT05422794 is a Phase 1 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8 that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 57 participants, below the 304-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (81% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05422794, a Phase 1 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
- 6
- Study locations
Study Summary
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.
Primary Outcome
A Bayesian optimal interval design will be used to identify the MTD.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Biopsy Procedure
- DRUG BET Bromodomain Inhibitor ZEN-3694
Study Locations (6)
Massachusetts
- Boston Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
New York
- NYU Langone Hospital - Long Island - Mineola
- Laura and Isaac Perlmutter Cancer Center at NYU Langone - New York
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Tennessee
- Vanderbilt Breast Center at One Hundred Oaks - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2023-05-18 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 1 |
What NCT05422794 shows while recruiting
NCT05422794 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 304-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (81% lower).
The record links to 5 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05422794 lists 6 locations in 4 states (Massachusetts, New York, Ohio).
Frequently Asked Questions
What is clinical trial NCT05422794 about?
NCT05422794 is a clinical study titled "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". 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 bo...
What is the current status of trial NCT05422794?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2023-05-18. Estimated completion is 2027-03-31.
What conditions does trial NCT05422794 study?
This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma, Unresectable Triple-Negative Breast Carcinoma, Locally Advanced Triple-Negative Breast Carcinoma.
What interventions are being tested in trial NCT05422794?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), BET Bromodomain Inhibitor ZEN-3694 (DRUG).
Who is sponsoring clinical trial NCT05422794?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05422794 being conducted?
This trial has 6 study locations across Massachusetts, New York, Ohio, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05422794's enrollment target sits among peer trials
57 47th of 84 higher than 37 of 84 other Anatomic Stage III Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage III Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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