Ibrutinib + Trastuzumab for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen byJoyce O'Shaughnessy, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: US Oncology Research

No Placebo Group

Breakthrough Therapy

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.

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.

+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.

+18 more

Participant Groups

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.

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.

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

🇪🇺 Approved in European Union as Imbruvica for: