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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
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Histologic or cytologic confirmation of HER2-amplified breast cancer according to most recent biopsy (local testing permitted)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
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 belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My latest biopsy confirms I have HER2-amplified breast cancer.
Select...
I have had 4 or fewer (Phase I) / 3 or fewer (Phase II) chemotherapy treatments for metastatic breast cancer.
Select...
I am a woman aged 18 or older.
Select...
My cancer worsened within 6 months after finishing TDM1 therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
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 moreOther outcome measures
Cytokine Gene Expression Analysis
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
Ibrutinib 560 mg
2019
Completed Phase 4
~80
Ibrutinib 420 mg
2019
Completed Phase 4
~80
Find a Location
Who is running the clinical trial?
US Oncology ResearchLead Sponsor
37 Previous Clinical Trials
17,436 Total Patients Enrolled
5 Trials studying Breast Cancer
4,252 Patients Enrolled for Breast Cancer
AbbVieIndustry Sponsor
954 Previous Clinical Trials
501,079 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to follow all study requirements.I have no lasting side effects from previous cancer treatments.I cannot swallow pills or have serious digestive system issues.I haven't had chemotherapy in the last 21 days.I haven't taken immunosuppressants in the last 28 days.I do not have any ongoing infections that aren't under control.I have not had major surgery within the last 4 weeks.I am currently taking warfarin or similar blood thinners.I haven't taken strong CYP3A inhibitors in the last 7 days.I understand the study's risks and can sign the consent form.I finished treatment for an infection less than 14 days ago.Your heart's pumping ability is normal based on tests like ECHO or MUGA.I can take care of myself and am up and about more than half of my waking hours.My latest biopsy confirms I have HER2-amplified breast cancer.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 have a serious heart condition that is currently causing symptoms.My brain cancer has not been treated or is not under control.I have not had a stroke or brain bleed in the last 6 months.I had cancer before, but it was treated successfully over 3 years ago and is not expected to come back.I haven't had a live vaccine in the last 4 weeks.I am a woman aged 18 or older.Your blood clotting time and levels are within the normal range.My liver disease is moderate to severe.I have a bleeding disorder or hemophilia.My cancer worsened within 6 months after finishing TDM1 therapy.You have metastatic disease that can be measured or evaluated using a specific method called RECIST (v1.1).I have a history of HIV or active hepatitis B or C.
Research Study Groups:
This trial has the following groups:- Group 1: Trastuzumab plus Ibrutinib 560 mg
- Group 2: Trastuzumab plus Ibrutinib 840 mg
- Group 3: Trastuzumab plus Ibrutinib 420 mg
- Group 4: Phase II- Trastuzumab plus Maximum Tolerated Dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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