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NCT03804944 · ClinicalTrials.gov registry record · Phase 2
Converting HR+ Breast Cancer Into an Individualized Vaccine
A Phase 2 study of Breast Cancer, sponsored by Weill Medical College of Cornell University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 8
- Study locations
NCT03804944: Recruiting Phase 2 study of Breast Cancer, sponsored by Weill Medical College of Cornell University.
NCT03804944 is a Phase 2 study of Breast Cancer that is actively recruiting participants, run by Weill Medical College of Cornell University. The registered enrollment target is 100 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 8 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03804944, a Phase 2 study of Breast Cancer, is actively recruiting participants, sponsored by Weill Medical College of Cornell University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 8
- Study locations
Study Summary
Newly diagnosed post-menopausal women with clinical stage II-III, HR+HER2- breast cancer are eligible to a randomized trial, concurrently open at five US academic institutions. Patients receiving 4 months of standard neoadjuvant hormonal therapy with letrozole are randomly assigned to one of 4 arms of a trial testing focal hypo-fractionated RT alone or with immunotherapy combinations.
Primary Outcome
Tolerability of adding immunotherapy to a combination of tumor radiotherapy and endocrine therapy in the neoadjuvant setting of newly diagnosed HR+ breast cancer patients will be assessed if no grade 3 or higher toxicities are observed in the first 8 patients of each arm. CTCAE version 5.0 will be used.
Conditions Studied
Interventions
- RADIATION Focal Radiation therapy
- DRUG Pembrolizumab (200mg IV for 30 minutes
- BIOLOGICAL CDX-301
Study Locations (8)
New York
- Icahn School of Medicine at Mt Sinai - New York
- New York Presbyterian Hospital - Queens - New York
- Weill Cornell Medicine New York Presbyterian Hospital - New York
- Brooklyn Methodist Hospital - NewYork Presbyterian - New York
Texas
- UT Southwestern Medical Center - Dallas
- Houston Methodist Cancer Center - Houston
California
- Cedars-Sinai Medical Center - Los Angeles
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2020-03-17 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What NCT03804944 shows while recruiting
NCT03804944 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Focal Radiation therapy is the first listed.
NCT03804944 lists 8 locations in 4 states (New York, Texas, California).
Frequently Asked Questions
What is clinical trial NCT03804944 about?
NCT03804944 is a clinical study titled "Converting HR+ Breast Cancer Into an Individualized Vaccine". Newly diagnosed post-menopausal women with clinical stage II-III, HR+HER2- breast cancer are eligible to a randomized trial, concurrently open at five US academic institutions. Patients receiving 4 months of standard neoadjuvant hormonal therapy with letrozole are randomly assigned to one of 4 arms ...
What is the current status of trial NCT03804944?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2020-03-17. Estimated completion is 2027-12-31.
What conditions does trial NCT03804944 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT03804944?
The interventions under investigation include: Focal Radiation therapy (RADIATION), Pembrolizumab (200mg IV for 30 minutes (DRUG), CDX-301 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03804944?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03804944 being conducted?
This trial has 8 study locations across California, New York, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT03804944's enrollment target sits among peer trials
100 565th of 1224 higher than 630 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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