Izalontamab Brengitecan for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called iza-bren (Izalontamab Brengitecan) for certain types of advanced breast cancer. It targets individuals with triple-negative breast cancer (TNBC) or a specific kind of estrogen receptor-low, HER2-negative breast cancer who cannot use other common therapies. The study compares iza-bren to standard treatments like paclitaxel or capecitabine. Suitable participants have breast cancer that cannot be surgically removed or has spread, and their cancer returned at least six months after their last treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that Izalontamab Brengitecan, a type of targeted cancer treatment, is being tested for safety and effectiveness in treating certain types of breast cancer. In earlier studies, patients generally tolerated the treatment well. Most side effects were mild to moderate, including nausea, tiredness, and low blood cell counts, which are common with many cancer treatments.
The trial's advanced stage suggests that earlier studies provided some evidence of the treatment's safety in humans. However, this does not eliminate all risks. It is important to consult with a doctor to determine if joining a trial is appropriate.
Why are researchers excited about this trial's treatments?
Researchers are excited about Izalontamab Brengitecan because it offers a novel approach to treating breast cancer. Unlike typical chemotherapy drugs that indiscriminately attack fast-growing cells, Izalontamab Brengitecan targets specific cancer cells with a unique mechanism of action. This targeted approach not only aims to be more effective in attacking cancer cells but also has the potential to reduce the side effects commonly associated with traditional chemotherapy treatments. Additionally, by focusing on specific proteins found on cancer cells, Izalontamab Brengitecan may improve outcomes for patients who haven't responded well to other treatments.
What evidence suggests that this trial's treatments could be effective for breast cancer?
Research has shown that izalontamab brengitecan, or iza-bren, yields promising results in treating breast cancer. In one study, 42.1% of patients experienced tumor shrinkage or disappearance, while 80.2% had stable cancer, meaning it did not worsen. In this trial, some participants will receive iza-bren, a treatment that targets two proteins (EGFR and HER3) on cancer cells and delivers chemotherapy directly to the tumor. This targeted approach may kill cancer cells more effectively while sparing healthy ones. These findings suggest iza-bren could be a promising treatment for certain breast cancer patients.12345
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
This trial is for individuals with triple-negative breast cancer that's advanced, can't be removed by surgery, or has spread. It's specifically for those who can't have anti-PD(L)1 drugs and hormone treatments. Participants should not have had prior treatment for their metastatic condition.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either iza-bren or treatment of physician's choice for first-line metastatic TNBC or ER-low, HER2-negative BC
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Capecitabine
- Carboplatin plus Gemcitabine
- Izalontamab Brengitecan
- Nab-paclitaxel
- Paclitaxel
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
SystImmune Inc.
Industry Sponsor