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Invasive Breast Carcinoma / Computed Tomography / Biopsy Procedure · Phase 2 Trial
ClinicalTrials.gov · August 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 2 trial registration for a combinatorial immunotherapy and chemotherapy regimen in metastatic triple-negative breast cancer, with and without a personalized neoantigen vaccine. No results have been posted to the registry; the study is currently recruiting. The trial is designed to evaluate progression-free survival at 6 and 12 months.
Phase 2, Interventional, Randomized, Parallel, Double masking, Treatment purpose. Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Metastatic Triple-Negative Breast Carcinoma; age from 18 Years. Intervention: Arm I (neoantigen vaccine, durvalumab, nab-paclitaxel). Compared with: Arm II (durvalumab, nab-paclitaxel) — Active Comparator. n = 86. 30 sites: United States.
This is a Phase 2 trial registration for a combinatorial immunotherapy and chemotherapy regimen in metastatic triple-negative breast cancer, with and without a personalized neoantigen vaccine. No results have been posted to the registry; the study is currently recruiting. The trial is designed to evaluate progression-free survival at 6 and 12 months.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
Results from this trial may inform the role of personalized neoantigen vaccines combined with checkpoint inhibitors and chemotherapy in metastatic TNBC, but no clinical guidance can be drawn until outcomes are available and published.
Phase 2 trial in recruitment with no results posted; study design and patient population are defined but outcomes remain unreported.
As stated by the source record.
Quoted from the source exactly as published.
Results from this trial may inform the role of personalized neoantigen vaccines combined with checkpoint inhibitors and chemotherapy in metastatic TNBC, but no clinical guidance can be drawn until outcomes are available and published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT03606967). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 86 participants (ESTIMATED). Conditions: Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Metastatic Triple-Negative Breast Carcinoma. Interventions: PROCEDURE: Biopsy Procedure; PROCEDURE: Biospecimen Collection; DRUG: Carboplatin; PROCEDURE: Computed Tomography; BIOLOGICAL: Durvalumab; DRUG: Gemcitabine Hydrochloride; PROCEDURE: Magnetic Resonance Imaging; DRUG: Nab-paclitaxel; BIOLOGICAL: Personalized Synthetic Long Peptide Vaccine; DRUG: Poly ICLC; BIOLOGICAL: Sacituzumab Govitecan; BIOLOGICAL: Tremelimumab. Primary outcome measures: Progression-free survival (PFS) , From initiation of Part B to progression or death, assessed at 6 and 12 months. Brief summary: This phase II trial studies how well nab-paclitaxel, durvalumab, and tremelimumab with or without personalized synthetic long peptide vaccine (neoantigen vaccine) works in treating patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether giving nab-paclitaxel, durvalumab, and tremelimumab with or without neoantigen vaccine will work better in treating patients with triple negative breast cancer.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.