18 and older, female only, with Triple Negative Breast Cancer or Anthracycline-refractory TNBC. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pathological Complete Response (pCR) Rate of Docetaxel Chemotherapy and Pembrolizumab Plus IL-12 Gene TherapyPrimary· 18 weeks
To determine the pCR rate of docetaxel chemotherapy and pembrolizumab plus IL-12 gene therapy in patients with TNBC per RECIST v1.1 assessed by CT Scan or MRI. CR: Disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter of target lesions, using the baseline sum longest diameter as a reference. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, using the smallest sum longest diameter as a reference. PD: At least a greater than or equal to 20% increase in the sum of the longest dimensions of the target lesions
Group
Value
95% CI
Experimental
1
Number of Participants With Treatment-related Adverse EventsSecondary· 18 weeks
To determine the number of participants with treatment-related adverse events, as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
Group
Value
95% CI
Experimental
8
Adverse events — posted to ClinicalTrials.gov
Time frame: At the time of informed consent through 90 days after last treatment dose, approximately 26 weeks (28 Days through screening + 4 - 21 day cycles + 90 days after last treatment dose on cycle 4 day 1).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Experimental
Serious: 6/8 (75%)
Deaths: 2/8
Serious adverse events (8 terms)
Reaction
System
Experimental
Ferbile Neutropenia
Blood and lymphatic system disorders
—
Sepsis
Infections and infestations
—
Hepatic Biliary disorders, other (Hepatic Toxicity)
The purpose of this research study is to test the safety and effectiveness of docetaxel chemotherapy and pembrolizumab plus adenoviral-mediated interleukin-12 (ADV/IL-12) gene therapy in patients with anthracycline-refractory, triple negative breast cancer (TNBC).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06724042 — Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors
· Phase 1
· not yet recruiting
NCT07361484 — Docetaxel Plus Plinabulin vs Docetaxel Plus Placebo in Advanced/Metastatic Non-Squamous NSCLC After PD-1/PD-L1 Therapy a
· Phase 3
· not yet recruiting
NCT07415031 — A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies
· Phase 2
· not yet recruiting
NCT07528274 — Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure
· Phase 2
· recruiting
NCT07487896 — A Study of YL201 Versus Investigator's Choice of Chemotherapy in Participants With Locally Advanced or Metastatic Esopha
· Phase 3
· not yet recruiting
Other recruiting trials for Triple Negative Breast Cancer
Currently open trials in the same condition.
NCT07533123 — A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who H
· Phase 3
· recruiting
NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types
· Phase 1
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The Methodist Hospital Research Institute
Last refreshed: 23 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04095689.