Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 1 study of Breast Neoplasms and Malignant Neoplasm of Breast, sponsored by US Oncology Research.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Highest dose of ibrutinib from Phase 1 (420, 560, or 840 mg by mouth daily) that had fewer than two dose-limiting toxicities in its respective cohort
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2017-11-29 |
| Est. Completion | 2025-01 |
| Phase | Phase 1 |
What the registry record for NCT03379428 still lists
NCT03379428 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 569-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (94% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Breast Neoplasms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03379428's enrollment target sits among peer trials
34 82nd of 97 higher than 16 of 97 other Breast Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Focused Ultrasound and Gemcitabine in Breast Cancer
RECRUITING · Phase 1
-
A Study of LY4337713 in Participants With FAP-Positive Solid Tumors
RECRUITING · Phase 1
-
Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer
RECRUITING · Phase 1
-
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
RECRUITING · Phase 1
-
Safety/Efficacy Study of CID-078 in Patients With Advanced Solid Tumor Malignancies
RECRUITING · Phase 1
-
A Study of DM001 in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02897063 · 34 participants · Phase 1
Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure
- NCT03906617 · 34 participants · Phase 4
Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine
- NCT03992378 · 34 participants · NA
Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis
- NCT04047849 · 34 participants · Phase 4
Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI