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NCT03112590 · ClinicalTrials.gov registry record · Phase 1

Phase I-II Study of Interferon-gamma in Patients With HER-2 Positive Breast Cancer

A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Completed
Registry status
Phase 1
Development phase
51
Enrollment target

NCT03112590 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 51 participants.

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The verdict

NCT03112590, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

COMPLETED
Registry status
Phase 1
Development phase
51 participants
Enrollment target

Study Summary

This purpose of this study is to evaluate the safety and to find the optimal dose in participants with human epidermal growth factor receptor 2 (HER2) positive breast cancer who are given the combination of Interferon-gamma with paclitaxel, trastuzumab and pertuzumab. This study will also look at other effects of Interferon-gamma with paclitaxel, trastuzumab and pertuzumab, including its effect on this type of cancer. Interferon-gamma is a biologically manufactured protein that is similar to a protein the body makes naturally. In the body, interferon gamma is produced by immune cells and helps to prevent serious infections.

Interventions

  • DRUG Trastuzumab
  • DRUG Paclitaxel
  • BIOLOGICAL Interferon-gamma (IFN-γ)
  • OTHER Pertuzumab
  • PROCEDURE Post Therapy Surgery

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2017-06-23
Est. Completion 2023-02-20
Phase Phase 1

What the Registry Record Tells You About NCT03112590

The ClinicalTrials.gov registry entry for NCT03112590 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Trastuzumab is the first listed.

NCT03112590 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03112590 about?

NCT03112590 is a clinical study titled "Phase I-II Study of Interferon-gamma in Patients With HER-2 Positive Breast Cancer". This purpose of this study is to evaluate the safety and to find the optimal dose in participants with human epidermal growth factor receptor 2 (HER2) positive breast cancer who are given the combination of Interferon-gamma with paclitaxel, trastuzumab and pertuzumab. This study will also look at ot...

What is the current status of trial NCT03112590?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2017-06-23. Estimated completion is 2023-02-20.

What interventions are being tested in trial NCT03112590?

The interventions under investigation include: Trastuzumab (DRUG), Paclitaxel (DRUG), Interferon-gamma (IFN-γ) (BIOLOGICAL), Pertuzumab (OTHER), Post Therapy Surgery (PROCEDURE).

Who is sponsoring clinical trial NCT03112590?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

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.