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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: Recruiting Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Invasive Breast Carcinoma, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The median PFS in each arm and their 80% confidence intervals will be assessed using Kaplan-Meier product limit methods and compared by log-rank test.
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 |
What NCT03606967 shows while recruiting
NCT03606967 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 165-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (58% lower).
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 names 20 study sites across 6 states, led by 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
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Where NCT03606967's enrollment target sits among peer trials
70 16th of 59 higher than 43 of 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage IV Breast Cancer AJCC v8 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.
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