Ibrutinib + Trastuzumab for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of ibrutinib (a pill) and trastuzumab (an IV drug) in patients with HER2-amplified Metastatic Breast Cancer that has worsened after previous treatment. Ibrutinib blocks proteins that help cancer grow, while trastuzumab helps the immune system attack cancer cells. Trastuzumab has been widely used in the treatment of HER2-positive breast cancer and has shown significant efficacy in combination with other therapies.
Who Is on the Research Team?
Joyce O'Shaughnessy, MD
Principal Investigator
US Oncology Research/McKesson Specialty Health
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Dose-escalation study to evaluate the maximum tolerated dose and dose-limiting toxicities of ibrutinib in combination with trastuzumab
Phase II Treatment
Treatment with the maximum tolerated dose of ibrutinib plus trastuzumab to assess clinical benefit rate
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ibrutinib
- Trastuzumab
Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
US Oncology Research
Lead Sponsor
AbbVie
Industry Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois
Pharmacyclics LLC.
Industry Sponsor
Dr. Maky Zanganeh
Pharmacyclics LLC.
Chief Executive Officer
Degree from Louis Pasteur University in Strasbourg, France; MBA from Schiller International University in France
Dr. Ellie Im
Pharmacyclics LLC.
Chief Medical Officer
MD from an unspecified institution