Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03606967 · ClinicalTrials.gov registry record · Phase 2
Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
A Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Invasive Breast Carcinoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 20
- Study locations
NCT03606967 is a Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Invasive Breast Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 70 participants, below the 165-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 6 states.
The verdict
NCT03606967, a Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Invasive Breast Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 165-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (58% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
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.
NCT03606967 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Florida, Missouri, California.
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.
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).
Who is sponsoring clinical trial NCT03606967?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Anatomic Stage IV Breast Cancer AJCC v8
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.
-
A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer
RECRUITING · Phase 2
-
Cemiplimab and Transarterial Radioembolization With Y-90 SIR-S Spheres for the Treatment of Liver Directed Metastatic Breast Cancer
RECRUITING · Phase 2
-
Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable, Locally Advanced Triple Negative Breast Cancer
RECRUITING · Phase 2
-
Stereotactic Body Radiation Therapy and FES PET/CT Imaging for the Treatment of Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer
RECRUITING · Phase 2
-
Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer
RECRUITING · Phase 2
-
Olaparib With Cediranib or AZD6738 for the Treatment of Advanced or Metastatic Germline BRCA Mutated Breast Cancer
RECRUITING · Phase 2
Explore more on PlainTrial
Anatomic Stage IV Breast Cancer AJCC v8
All registered trials for this condition
Invasive Breast Carcinoma
All registered trials for this condition
California
All trials with a study site in California
Recruiting now
Find trials open to new participants near you
Rankings
Top sponsors, conditions, and phases
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.