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NCT04090398 · ClinicalTrials.gov registry record · Phase 2

Testing the Addition of Radium Therapy (Radium-223 Dichloride) to the Usual Chemotherapy Treatment (Paclitaxel) for Advanced Breast Cancer That Has Spread to the Bones

A Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Bone, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 2
Development phase
70
Enrollment target
20
Study locations

NCT04090398 is a Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Bone that is active but no longer recruiting, 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 7 states.

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The verdict

NCT04090398, a Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Bone, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
70 participants
Enrollment target
20
Study locations

Study Summary

This phase II trial studies how well radium-223 dichloride and paclitaxel work in treating patients with advanced breast cancer that has spread to the bones. Radium-223 dichloride is a radioactive drug that behaves in a similar way to calcium and collects in cancer that has spread to the bones (bone metastases). The radioactive particles in radium-223 dichloride act on bone metastases, killing the tumor cells and reducing the pain that they can cause. Drugs used in chemotherapy, such as 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. Giving radium-223 dichloride and paclitaxel may work better in treating patients with metastatic breast cancer compared to paclitaxel alone.

Conditions Studied

Anatomic Stage IV Breast Cancer AJCC v8 Metastatic Malignant Neoplasm in the Bone Metastatic HER2-Negative Breast Carcinoma

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Magnetic Resonance Imaging
  • PROCEDURE Bone Scan
  • OTHER Electronic Health Record Review

Study Locations (20)

Florida

  • 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

Kansas

  • University of Kansas Clinical Research Center - Fairway
  • University of Kansas Cancer Center - Kansas City
  • University of Kansas Cancer Center-Overland Park - Overland Park
  • University of Kansas Health System Saint Francis Campus - Topeka
  • University of Kansas Hospital-Westwood Cancer Center - Westwood

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
  • University of California Davis Comprehensive Cancer Center - Sacramento

Illinois

  • University of Chicago Comprehensive Cancer Center - Chicago
  • UC Comprehensive Cancer Center at Silver Cross - New Lenox
  • University of Chicago Medicine-Orland Park - Orland Park

Michigan

  • Wayne State University/Karmanos Cancer Institute - Detroit
  • Weisberg Cancer Treatment Center - Farmington Hills

Alabama

  • University of Alabama at Birmingham Cancer Center - Birmingham

Kentucky

  • University of Kentucky/Markey Cancer Center - Lexington

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2020-08-04
Est. Completion 2026-06-30
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04090398

The ClinicalTrials.gov registry entry for NCT04090398 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 165-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (58% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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 Biospecimen Collection is the first listed.

NCT04090398 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, Kansas, California.

Frequently Asked Questions

What is clinical trial NCT04090398 about?

NCT04090398 is a clinical study titled "Testing the Addition of Radium Therapy (Radium-223 Dichloride) to the Usual Chemotherapy Treatment (Paclitaxel) for Advanced Breast Cancer That Has Spread to the Bones". This phase II trial studies how well radium-223 dichloride and paclitaxel work in treating patients with advanced breast cancer that has spread to the bones. Radium-223 dichloride is a radioactive drug that behaves in a similar way to calcium and collects in cancer that has spread to the bones (bone...

What is the current status of trial NCT04090398?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2020-08-04. Estimated completion is 2026-06-30.

What conditions does trial NCT04090398 study?

This clinical trial studies the following conditions: Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Malignant Neoplasm in the Bone, Metastatic HER2-Negative Breast Carcinoma.

What interventions are being tested in trial NCT04090398?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Bone Scan (PROCEDURE), Electronic Health Record Review (OTHER).

Who is sponsoring clinical trial NCT04090398?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04090398 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.