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Bruton's Tyrosine Kinase (BTK) Inhibitor

Ibrutinib + Trastuzumab for Breast Cancer

Phase 1 & 2
Waitlist Available
Led By Joyce O'Shaughnessy, MD
Research Sponsored by US Oncology Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female, Age ≥ 18 years
Histologic or cytologic confirmation of HER2-amplified breast cancer according to most recent biopsy (local testing permitted)
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing ibrutinib given with trastuzumab to see if it is safe and what the highest dose that can be given is. It is for people with HER2-positive metastatic breast cancer that has gotten worse after other treatments.

Who is the study for?
This trial is for women aged 18 or older with HER2-amplified metastatic breast cancer that worsened after T-DM1 therapy. Participants can have had up to four prior chemotherapy treatments, must not be pregnant, and agree to use two effective birth control methods. They should have good heart function (LVEF ≥ 50%), adequate blood counts, liver and kidney function, and an ECOG performance status of 0-2.Check my eligibility
What is being tested?
The study tests different doses of Ibrutinib (560 mg, 840 mg, or 420 mg daily) combined with Trastuzumab administered intravenously. It aims to find the highest dose patients can take without serious side effects in those who've previously been treated with ado-trastuzumab emtansine for metastatic breast cancer.See study design
What are the potential side effects?
Possible side effects include bleeding disorders due to Ibrutinib's effect on blood clotting; digestive issues from swallowing capsules; potential heart problems; risk of infection; fatigue; nausea; diarrhea; rash; muscle spasms and bone pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am a woman aged 18 or older.
My latest biopsy confirms I have HER2-amplified breast cancer.
My cancer worsened within 6 months after finishing TDM1 therapy.
I have had 4 or fewer (Phase I) / 3 or fewer (Phase II) chemotherapy treatments for metastatic breast cancer.
My blood counts are stable without transfusions or medications for at least a week.
My liver and kidneys are working well.
I can take care of myself and am up and about more than half of my waking hours.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase I: Maximum Tolerated Dose
Phase II: Clinical Benefit Rate
Secondary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of ibrutinib plus trastuzumab.
Median Overall Survival
Median Progression-free Survival
+3 more
Other outcome measures
Cytokine Gene Expression Analysis

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Trastuzumab plus Ibrutinib 840 mgExperimental Treatment2 Interventions
If no patients in 560 mg arm have DLTs, this arm will be opened in Phase I to see how this higher dose is tolerated.
Group II: Trastuzumab plus Ibrutinib 560 mgExperimental Treatment2 Interventions
In Phase I, starting dose of Ibrutinib will be 560 mg orally per day. 3 patients will be enrolled first. If none of these have DLTs, 3 new patients will be enrolled at the next higher Ibrutinib dose level (840 mg orally per day). If 1 of these 3 patients have a DLT, expand this arm to 6 patients. If 2 or more of these 6 patients have a DLT, enroll 3 patients in lower dose lever (420 mg).
Group III: Trastuzumab plus Ibrutinib 420 mgExperimental Treatment2 Interventions
If 2 or more patients in 560 mg arm have DLTs, this arm will be opened in Phase I to see how this lower dose is tolerated.
Group IV: Phase II- Trastuzumab plus Maximum Tolerated DoseExperimental Treatment1 Intervention
Maximum tolerated dose from Phase I will be used here in Phase II.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4
Ibrutinib 560 mg
Completed Phase 4
Ibrutinib 420 mg
Completed Phase 4

Find a Location

Who is running the clinical trial?

US Oncology ResearchLead Sponsor
36 Previous Clinical Trials
16,436 Total Patients Enrolled
5 Trials studying Breast Cancer
4,252 Patients Enrolled for Breast Cancer
AbbVieIndustry Sponsor
938 Previous Clinical Trials
494,929 Total Patients Enrolled
7 Trials studying Breast Cancer
454 Patients Enrolled for Breast Cancer
Pharmacyclics LLC.Industry Sponsor
113 Previous Clinical Trials
13,794 Total Patients Enrolled
1 Trials studying Breast Cancer
124 Patients Enrolled for Breast Cancer

Media Library

Ibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03379428 — Phase 1 & 2
Breast Cancer Research Study Groups: Trastuzumab plus Ibrutinib 560 mg, Trastuzumab plus Ibrutinib 840 mg, Trastuzumab plus Ibrutinib 420 mg, Phase II- Trastuzumab plus Maximum Tolerated Dose
Breast Cancer Clinical Trial 2023: Ibrutinib Highlights & Side Effects. Trial Name: NCT03379428 — Phase 1 & 2
Ibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03379428 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the key targets of this investigation?

"This 24-month trial has two major objectives: determining the maximum tolerated dose of ibrutinib plus trastuzumab and evaluating safety/tolerability through CTCAE v4.03 criteria, as well as median overall survival and progression-free survival associated with this treatment plan."

Answered by AI

Could you elaborate on any past endeavors that have studied the effects of Trastuzumab?

"Currently, the database of Trastuzumab-based clinical trials includes 346 active studies. Of those, 72 are in Phase 3 and have been conducted at 21679 different sites worldwide; with Seattle, Washington being one of them."

Answered by AI

For what medical conditions is Trastuzumab commonly prescribed?

"Trastuzumab is a beneficial therapy for breast cancer, as well as other maladies such as high risk of recurrence, initial treatment plans and Waldenstrom macroglobulinemia."

Answered by AI

Is it currently possible for subjects to enroll in this experiment?

"Affirmative, according to the details posted on clinicaltrials.gov this trial is actively recruiting participants. This initiative was first publicized in November 29th 2017 and most recently edited on May 16th 2022. The study requires 51 patients from a single site for full enrollment."

Answered by AI

How many participants are included in this research study?

"That is correct. The information on clinicaltrials.gov attests to this trial's current recruitment phase, which began in November of 2017 and was most recently revised on May 16th 2022. A total of 51 patients are sought from one single medical centre."

Answered by AI
~1 spots leftby Jun 2024