Study on Ibrutinib and Trastuzumab for HER2-Positive Metastatic Breast Cancer

Sponsor: US Oncology Research

Sponsor score: 0

ClinicalTrials ID:NCT03379428

Provider View

This clinical trial is testing a combination of two drugs, ibrutinib and trastuzumab, to find the best dose and check for side effects in patients with HER2-positive metastatic breast cancer that has worsened after previous treatment.

Patient Parameters

Program Overview

The study aims to determine the safest and most effective dose of ibrutinib, taken orally, when combined with trastuzumab, given through a vein, for patients with HER2-positive metastatic breast cancer. This cancer has progressed despite previous treatment with a drug called ado-trastuzumab emtansine (T-DM1).

Description

This trial is exploring a new treatment option for patients with HER2-positive metastatic breast cancer that has not responded well to previous therapies. The study focuses on combining ibrutinib, a drug taken by mouth, with trastuzumab, which is given intravenously. Ibrutinib is already used for other types of cancer and has shown promise in laboratory studies for treating HER2-positive breast cancer. The goal is to find the maximum dose that patients can tolerate without severe side effects and to see if this combination can help control the cancer. The study will enroll up to 51 patients to test different doses and monitor their health and response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older.
  • Confirmed diagnosis of HER2-positive breast cancer.
  • Cancer that has spread and can be measured by scans.
  • Disease progression within 6 months after T-DM1 therapy.
  • No more than 4 previous chemotherapy treatments for metastatic breast cancer.
  • Good blood, liver, and kidney function based on specific tests.
  • Heart function of at least 50%.
  • ECOG performance status of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
  • Negative pregnancy test for women of childbearing potential.
  • Willingness to use effective birth control during the study and for 30 days after.
  • Signed informed consent and authorization to use health information.

Exclusion Criteria

  • Uncontrolled or untreated brain metastases.
  • Recent chemotherapy within 21 days before starting the study.
  • History of other cancers unless treated and inactive for 3 years.
  • Use of immunosuppressant therapy within 28 days before the study.
  • Recent live vaccines within 4 weeks before the study.
  • Recent infection requiring treatment within 14 days before the study.
  • Unresolved side effects from previous cancer treatments.
  • Known bleeding disorders or recent stroke.
  • Active infections like HIV, hepatitis B, or C.
  • Major surgery within 4 weeks before the study.
  • Serious heart conditions or recent heart attack.
  • Difficulty swallowing pills or severe digestive issues.
  • Use of certain blood thinners or medications affecting liver enzymes.
  • Pregnant or breastfeeding women.
  • Inability to participate in study procedures or understand the study details.

Locations

FACILITYZIPCITYSTATE
10 sites incl TX, WA, VA, and NV75246DallasTexas

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