34 Participants Needed

Ibrutinib + Trastuzumab for Breast Cancer

NS
Overseen ByNina Salazar
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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?

JO

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

Signed informed consent obtained prior to any screening procedures
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.
See 11 more

Exclusion 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.
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Dose-escalation study to evaluate the maximum tolerated dose and dose-limiting toxicities of ibrutinib in combination with trastuzumab

24 months
Regular visits for dose escalation and monitoring

Phase II Treatment

Treatment with the maximum tolerated dose of ibrutinib plus trastuzumab to assess clinical benefit rate

24 months
Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ibrutinib
  • Trastuzumab
Trial Overview 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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Trastuzumab plus Ibrutinib 840 mgExperimental Treatment2 Interventions
Group II: Trastuzumab plus Ibrutinib 560 mgExperimental Treatment2 Interventions
Group III: Trastuzumab plus Ibrutinib 420 mgExperimental Treatment2 Interventions
Group IV: Phase II- Trastuzumab plus Maximum Tolerated DoseExperimental Treatment1 Intervention

Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Imbruvica for:
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Approved in United States as Imbruvica for:
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Approved in Canada as Imbruvica for:
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Approved in Japan as Imbruvica for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

US Oncology Research

Lead Sponsor

Trials
38
Recruited
17,400+

AbbVie

Industry Sponsor

Trials
1,079
Recruited
535,000+
Founded
2013
Headquarters
North Chicago, USA
Known For
Immunology treatments
Top Products
Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Pharmacyclics LLC.

Industry Sponsor

Trials
114
Recruited
13,800+

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

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