Ibrutinib + Trastuzumab for Breast Cancer

Overseen By Nina Salazar

Age: 18+

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: US Oncology Research

Must not be taking: Immunosuppressants, Warfarin, CYP3A inhibitors

Disqualifiers: CNS metastases, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

34 Participants Needed

Trial Summary

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.

Research Team

Joyce O'Shaughnessy, MD

Principal Investigator

US Oncology Research/McKesson Specialty Health

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Trastuzumab plus Ibrutinib 840 mg Experimental Treatment 2 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 mg Experimental Treatment 2 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 mg Experimental Treatment 2 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 Dose Experimental Treatment 1 Intervention

Maximum tolerated dose from Phase I will be used here in Phase II.

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

Approved in European Union as Imbruvica for:

• Chronic lymphocytic leukemia
• Mantle cell lymphoma
• Waldenström's macroglobulinemia
• Marginal zone lymphoma
• Graft-versus-host disease

Approved in United States as Imbruvica for:

• Chronic lymphocytic leukemia/small lymphocytic lymphoma
• Mantle cell lymphoma
• Waldenström's macroglobulinemia
• Marginal zone lymphoma
• Graft-versus-host disease

Approved in Canada as Imbruvica for:

• Chronic lymphocytic leukemia
• Mantle cell lymphoma
• Waldenström's macroglobulinemia
• Marginal zone lymphoma

Approved in Japan as Imbruvica for:

• Chronic lymphocytic leukemia
• Mantle cell lymphoma
• Waldenström's macroglobulinemia

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

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