Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04373031 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab, IRX-2, and Chemotherapy in Triple Negative Breast Cancer
A Phase 2 study of Breast Cancer and Breast Neoplasms, sponsored by Providence Health & Services.
- Active
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT04373031: Active Phase 2 study of Breast Cancer and Breast Neoplasms, sponsored by Providence Health & Services.
NCT04373031 is a Phase 2 study of Breast Cancer and Breast Neoplasms that is active but no longer recruiting, run by Providence Health & Services. The registered enrollment target is 12 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04373031, a Phase 2 study of Breast Cancer and Breast Neoplasms, is active but no longer recruiting, sponsored by Providence Health & Services.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase II, randomized, open-label trial to evaluate the clinical and immunologic activity of pembrolizumab plus chemotherapy when combined with various immunotherapy induction regimens as neoadjuvant therapy for triple negative breast cancer (TNBC).
Primary Outcome
Number of patients who showed pCR post surgery. pCR rate (ypT0/Tis ypN0) is defined as the proportion of subjects without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy per the current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG IRX 2
Study Locations (1)
Oregon
- Providence Portland Medical Center - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-12-30 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
What the registry record for NCT04373031 still lists
NCT04373031 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04373031 reports a single indexed study location in Oregon.
Frequently Asked Questions
What is clinical trial NCT04373031 about?
NCT04373031 is a clinical study titled "Pembrolizumab, IRX-2, and Chemotherapy in Triple Negative Breast Cancer". This is a Phase II, randomized, open-label trial to evaluate the clinical and immunologic activity of pembrolizumab plus chemotherapy when combined with various immunotherapy induction regimens as neoadjuvant therapy for triple negative breast cancer (TNBC).
What is the current status of trial NCT04373031?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2020-12-30. Estimated completion is 2025-12.
What conditions does trial NCT04373031 study?
This clinical trial studies the following conditions: Breast Cancer, Breast Neoplasms.
What interventions are being tested in trial NCT04373031?
The interventions under investigation include: Pembrolizumab (DRUG), IRX 2 (DRUG).
Who is sponsoring clinical trial NCT04373031?
This trial is sponsored by Providence Health & Services, which has 69 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04373031 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04373031's enrollment target sits among peer trials
12 1167th of 1224 higher than 54 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC
RECRUITING · Phase 2
-
The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer
RECRUITING · Phase 2
-
Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC
RECRUITING · Phase 2
-
Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial
RECRUITING · Phase 2
-
Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score
RECRUITING · Phase 2
-
Precision Medicine in Action: Phase II Trial of Response Adaptive Ablative Pre-operative SPBI (RAPS) and Non-operative Sentinel Lymph Node Biopsy in Patients With Early-stage ER+ Breast Cancer: RAPS Trial
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02602769 · 12 participants
Whole Transcriptome Profiling and Metabolic Phenotyping in Children With ROHHAD Syndrome
- NCT02605421 · 12 participants · Phase 2
Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma
- NCT02619448 · 12 participants · Early Phase 1
Concurrent Chemotherapy Plus HFR Radiation Therapy in Inoperable NSCLC
- NCT03311503 · 12 participants · Phase 1
Phase I/II Trial of Lentiviral Gene Transfer for SCID-X1 With Low Dose Targeted Busulfan Conditioning
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI