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NCT03379428 · ClinicalTrials.gov registry record · Phase 1

Trial of Ibrutinib Plus Trastuzumab in HER2-amplified Metastatic Breast Cancer

A Phase 1 study of Breast Neoplasms and Malignant Neoplasm of Breast, sponsored by US Oncology Research.

Active
Registry status
Phase 1
Development phase
34
Enrollment target
1
Study location

NCT03379428 is a Phase 1 study of Breast Neoplasms and Malignant Neoplasm of Breast that is active but no longer recruiting, run by US Oncology Research. The registered enrollment target is 34 participants, below the 569-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03379428, a Phase 1 study of Breast Neoplasms and Malignant Neoplasm of Breast, is active but no longer recruiting, sponsored by US Oncology Research.

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

Study Summary

This is a Phase I/II, open-label dose-escalation study designed to evaluate the maximum tolerated dose (MTD) and dose-limiting side effects of ibrutinib (560 or 840 or 420 mg daily oral dose), given in combination with trastuzumab administered through the vein, in patients with HER2-amplified Metastatic Breast Cancer that has gotten worse after prior therapy with ado-trastuzumab emtansine (T-DM1).

Conditions Studied

Breast Neoplasms Malignant Neoplasm of Breast

Interventions

  • DRUG Trastuzumab
  • DRUG Ibrutinib 560 mg
  • DRUG Ibrutinib 840 mg
  • DRUG Ibrutinib 420 mg

Study Locations (1)

Texas

  • 10 sites incl TX, WA, VA, and NV - Dallas

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2017-11-29
Est. Completion 2025-01
Phase Phase 1

Sponsor

US Oncology Research

27 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03379428

The ClinicalTrials.gov registry entry for NCT03379428 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 569-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (94% lower). The listed sponsor is US Oncology Research, which has 27 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Breast Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Trastuzumab is the first listed.

NCT03379428 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT03379428 about?

NCT03379428 is a clinical study titled "Trial of Ibrutinib Plus Trastuzumab in HER2-amplified Metastatic Breast Cancer". This is a Phase I/II, open-label dose-escalation study designed to evaluate the maximum tolerated dose (MTD) and dose-limiting side effects of ibrutinib (560 or 840 or 420 mg daily oral dose), given in combination with trastuzumab administered through the vein, in patients with HER2-amplified Metast...

What is the current status of trial NCT03379428?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2017-11-29. Estimated completion is 2025-01.

What conditions does trial NCT03379428 study?

This clinical trial studies the following conditions: Breast Neoplasms, Malignant Neoplasm of Breast.

What interventions are being tested in trial NCT03379428?

The interventions under investigation include: Trastuzumab (DRUG), Ibrutinib 560 mg (DRUG), Ibrutinib 840 mg (DRUG), Ibrutinib 420 mg (DRUG).

Who is sponsoring clinical trial NCT03379428?

This trial is sponsored by US Oncology Research, which has 27 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03379428 being conducted?

This trial has 1 study location across 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.