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NCT03366844 · ClinicalTrials.gov registry record · Phase 1

Breast Cancer Study of Preoperative Pembrolizumab + Radiation

A Phase 1 study of Breast Cancer, sponsored by Stephen Shiao.

Active
Registry status
Phase 1
Development phase
66
Enrollment target
1
Study location

NCT03366844: Active Phase 1 study of Breast Cancer, sponsored by Stephen Shiao.

NCT03366844 is a Phase 1 study of Breast Cancer that is active but no longer recruiting, run by Stephen Shiao. The registered enrollment target is 66 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03366844, a Phase 1 study of Breast Cancer, is active but no longer recruiting, sponsored by Stephen Shiao.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
66 participants
Enrollment target
1
Study location

Study Summary

This study is being done to assess the feasibility of pembrolizumab (study drug) combined with standard radiation to the tumor (tumor boost) before patients undergo standard treatment that can consist of one or more of the following: breast-conserving surgery, radiation to the entire breast/chest wall after surgery, and chemotherapy. Study participants will receive two doses of the study drug intravenously (through the vein) before their planned breast surgery or chemotherapy. The study drug will be administered three weeks apart. At the time of the second dose, radiation to the tumor in the affected breast will be given. This type of radiation treatment is called a "tumor boost", which is a standard part of radiation therapy for breast cancer that may occur either before or after planned breast-conserving surgery. Patients will receive breast surgery or begin chemotherapy approximately six weeks after your first dose of the study drug.

Conditions Studied

Interventions

  • DRUG Pembrolizumab
  • RADIATION RT Boost

Study Locations (1)

California

  • Cedars-Sinai Medical Center - Los Angeles

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2017-12-22
Est. Completion 2030-12-07
Phase Phase 1

Sponsor

Stephen Shiao

3 total trials

What the Registry Record Tells You About NCT03366844

The ClinicalTrials.gov registry entry for NCT03366844 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 66 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 (98% lower). The listed sponsor is Stephen Shiao, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.

NCT03366844 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT03366844 about?

NCT03366844 is a clinical study titled "Breast Cancer Study of Preoperative Pembrolizumab + Radiation". This study is being done to assess the feasibility of pembrolizumab (study drug) combined with standard radiation to the tumor (tumor boost) before patients undergo standard treatment that can consist of one or more of the following: breast-conserving surgery, radiation to the entire breast/chest wa...

What is the current status of trial NCT03366844?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2017-12-22. Estimated completion is 2030-12-07.

What conditions does trial NCT03366844 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT03366844?

The interventions under investigation include: Pembrolizumab (DRUG), RT Boost (RADIATION).

Who is sponsoring clinical trial NCT03366844?

This trial is sponsored by Stephen Shiao, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03366844 being conducted?

This trial has 1 study location across California. 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

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, the data changelog, or report a data error.