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NCT03364348 · ClinicalTrials.gov registry record · Phase 1

4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer

A Phase 1 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma, sponsored by George W. Sledge Jr..

Completed
Registry status
Phase 1
Development phase
18
Enrollment target
1
Study location

NCT03364348 is a Phase 1 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma that has completed, run by George W. Sledge Jr.. The registered enrollment target is 18 participants, below the 66-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03364348, a Phase 1 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma, has completed, sponsored by George W. Sledge Jr..

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target
1
Study location

Study Summary

This trial studies the best dose and side effects of utomilumab (4-1BB agonist monoclonal antibody PF-05082566) with trastuzumab emtansine or trastuzumab in treating patients with HER2-positive breast cancer that has spread to other places in the body. Monoclonal antibodies, such as utomilumab, trastuzumab emtansine, and trastuzumab may interfere with the ability of tumor cells to grow and spread.

Interventions

  • DRUG Trastuzumab
  • DRUG Utomilumab
  • DRUG Ado-Trastuzumab Emtansine

Study Locations (1)

California

  • Stanford University, School of Medicine - Palo Alto

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2017-10-30
Est. Completion 2022-02-14
Phase Phase 1

Sponsor

George W. Sledge Jr.

1 total trials

What the Registry Record Tells You About NCT03364348

The ClinicalTrials.gov registry entry for NCT03364348 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 66-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (73% lower). The listed sponsor is George W. Sledge Jr., which has 1 total studies on file at ClinicalTrials.gov.

The record links to 7 conditions, with Stage IV Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Trastuzumab is the first listed.

NCT03364348 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT03364348 about?

NCT03364348 is a clinical study titled "4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer". This trial studies the best dose and side effects of utomilumab (4-1BB agonist monoclonal antibody PF-05082566) with trastuzumab emtansine or trastuzumab in treating patients with HER2-positive breast cancer that has spread to other places in the body. Monoclonal antibodies, such as utomilumab, tras...

What is the current status of trial NCT03364348?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2017-10-30. Estimated completion is 2022-02-14.

What conditions does trial NCT03364348 study?

This clinical trial studies the following conditions: Stage IV Breast Cancer, Recurrent Breast Carcinoma, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer.

What interventions are being tested in trial NCT03364348?

The interventions under investigation include: Trastuzumab (DRUG), Utomilumab (DRUG), Ado-Trastuzumab Emtansine (DRUG).

Who is sponsoring clinical trial NCT03364348?

This trial is sponsored by George W. Sledge Jr., which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03364348 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 Editorial

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