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ACTIVE NOT RECRUITING Phase 1

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

NCT03379428 · View on ClinicalTrials.gov ↗

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).

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

9 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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Oncology Research, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03379428 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03379428?

This trial is sponsored by US Oncology Research, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial