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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 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.

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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.

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

FieldValue
Enrollment Target 100 participants
Start Date 2020-03-17
Est. Completion 2027-12-31
Phase Phase 2

What the Registry Record Tells You About NCT03804944

The ClinicalTrials.gov registry entry for NCT03804944 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.

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 reports 8 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.