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Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
NCT03606967 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Carboplatin
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- BIOLOGICAL Durvalumab
Study Locations (20)
Florida
- UM Sylvester Comprehensive Cancer Center at Aventura — Aventura
- UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach
- University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami
- UM Sylvester Comprehensive Cancer Center at Kendall — Miami
- UM Sylvester Comprehensive Cancer Center at Plantation — Plantation
- Moffitt Cancer Center-International Plaza — Tampa
- Moffitt Cancer Center - McKinley Campus — Tampa
- Moffitt Cancer Center — Tampa
- Moffitt Cancer Center at Wesley Chapel — Wesley Chapel
Missouri
- Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters
- Siteman Cancer Center at West County Hospital — Creve Coeur
- Washington University School of Medicine — St Louis
- Siteman Cancer Center-South County — St Louis
California
- UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange
- University of California Davis Comprehensive Cancer Center — Sacramento
Connecticut
- Smilow Cancer Hospital Care Center at Saint Francis — Hartford
- Yale University — New Haven
Colorado
- UCHealth University of Colorado Hospital — Aurora
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2021-04-13 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03606967
The ClinicalTrials.gov registry entry for NCT03606967 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Anatomic Stage IV Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions — of which Carboplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03606967 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, Missouri, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03606967 about?
NCT03606967 is a clinical study titled "Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer". 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 ...
What is the current status of trial NCT03606967?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2021-04-13. Estimated completion is 2026-12-30.
What conditions does trial NCT03606967 study?
This clinical trial studies the following conditions: Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Metastatic Triple-Negative Breast Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03606967?
The interventions under investigation include: Carboplatin (DRUG), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Durvalumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03606967?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03606967 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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