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NCT04331067 · ClinicalTrials.gov registry record · Phase 1
Neoadjuvant Nivolumab and Chemotherapy in Patients With Localized Triple-negative Breast Cancer
A Phase 1 study of Triple Negative Breast Cancer, sponsored by Washington University School of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT04331067: Active Phase 1 study of Triple Negative Breast Cancer, sponsored by Washington University School of Medicine.
NCT04331067 is a Phase 1 study of Triple Negative Breast Cancer that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 15 participants, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04331067, a Phase 1 study of Triple Negative Breast Cancer, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Prior to Amendment #7: The hypothesis of this study is that the combination of cabiralizumab and nivolumab with neoadjuvant chemotherapy will decrease tumor associated macrophages (TAMs) and increase tumor infiltrating lymphocytes (TIL) compared to neoadjuvant chemotherapy plus nivolumab in patients with early stage triple-negative breast cancer (TNBC) and improve clinical outcomes. As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. The hypothesis of this study is that on-treatment tumor associated macrophages (TAMs) and tumor infiltrating lymphocytes (TILs) will improve (reduced TAMs, increased TILs) following neoadjuvant nivolumab with chemotherapy.
Primary Outcome
-Stromal TIL score is defined as the percentage of tumor stroma area that was occupied by mononuclear inflammatory cells.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- BIOLOGICAL Nivolumab
- PROCEDURE Tumor biopsy
- BIOLOGICAL Cabiralizumab
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2020-11-19 |
| Est. Completion | 2026-05-31 |
| Phase | Phase 1 |
What the registry record for NCT04331067 still lists
NCT04331067 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT04331067 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT04331067 about?
NCT04331067 is a clinical study titled "Neoadjuvant Nivolumab and Chemotherapy in Patients With Localized Triple-negative Breast Cancer". Prior to Amendment #7: The hypothesis of this study is that the combination of cabiralizumab and nivolumab with neoadjuvant chemotherapy will decrease tumor associated macrophages (TAMs) and increase tumor infiltrating lymphocytes (TIL) compared to neoadjuvant chemotherapy plus nivolumab in patients...
What is the current status of trial NCT04331067?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2020-11-19. Estimated completion is 2026-05-31.
What conditions does trial NCT04331067 study?
This clinical trial studies the following conditions: Triple Negative Breast Cancer.
What interventions are being tested in trial NCT04331067?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Nivolumab (BIOLOGICAL), Tumor biopsy (PROCEDURE), Cabiralizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04331067?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04331067 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Triple Negative 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 NCT04331067's enrollment target sits among peer trials
15 108th of 118 higher than 10 of 118 other Triple Negative Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Triple Negative 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.
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