Study of Izalontamab Brengitecan Compared to Standard Chemotherapy in Untreated Triple-negative or ER-low, HER2-negative Breast Cancer Patients Not Eligible for Anti-PD1/PD-L1 Treatment
This study focuses on Triple-negative Breast Cancer and ER-low, HER2-negative Breast Cancer that cannot be removed by surgery or has spread to other parts of the body. The study compares a new medicine called izalontamab brengitecan (also known as BL-B01D1) with standard chemotherapy treatments including paclitaxel, paclitaxel albumin-bound, capecitabine, or a combination of carboplatin and gemcitabine.
The main purpose of this research is to determine if izalontamab brengitecan works better than standard chemotherapy treatments in patients who cannot receive certain types of immunotherapy treatments (anti-PD1/PD-L1). The study will measure how long patients live without their cancer getting worse and their overall survival time. During treatment, some patients may also receive pegfilgrastim, a supportive care medicine that helps the body make white blood cells.
The medications will be given in different ways – some through an intravenous infusion directly into a vein, while others, like capecitabine, are taken by mouth as tablets. The study will continue for several years to gather information about how well the treatments work and how safe they are for patients.
1Initial assessment
Your doctor will confirm if you have triple-negative breast cancer (TNBC) or ER-low, HER2-negative breast cancer that cannot be removed by surgery or has spread.
Your previous treatments must be completed at least 2 weeks before starting the study.
A brain scan (MRI or CT) will be performed within 28 days before starting.
2Treatment assignment
You will be randomly assigned to receive either the new medicine izalontamab brengitecan (iza-bren) or one of these standard treatments:
– Paclitaxel (given through a vein)
– Paclitaxel albumin-bound (given through a vein)
– Capecitabine (taken by mouth)
– Carboplatin plus gemcitabine (both given through a vein)
3Treatment period
Your treatment will continue as long as it is helping and you are not experiencing serious side effects.
Regular scans will be performed to check if the cancer is stable or getting better or worse.
Your doctor will monitor your health status throughout the treatment.
4Follow-up period
After treatment ends, your health will continue to be monitored.
The study will track how long you live without the cancer getting worse (progression-free survival).
The study will also track overall survival time.
5Study completion
The study is expected to run until February 2031.
Your participation may end earlier if the treatment stops working or you experience serious side effects.
Who Can Join the Study?
You must have advanced triple-negative breast cancer or ER-low, HER2-negative breast cancer that cannot be surgically removed or has spread to other parts of the body
You must not have received any previous treatments for this stage of cancer
You must have completed any previous local cancer treatments (such as radiation therapy or major surgery) at least 2 weeks before starting the study
Your cancer must be measurable through CT scan or MRI (special imaging tests that create detailed pictures of your body)
You must have had a brain MRI (or CT scan if you cannot have an MRI) within 28 days before starting the study
You must be able to receive at least one of these chemotherapy treatments: paclitaxel, nab-paclitaxel, capecitabine, or carboplatin plus gemcitabine
You must have an ECOG performance status of 0 or 1 (this means you must be able to perform most daily activities on your own)
Any side effects from previous treatments must have improved to mild levels or disappeared (except for hair loss or nerve problems, which can be moderate)
If you have triple-negative breast cancer, you must not be eligible for first-line treatment with medications like pembrolizumab or atezolizumab
If you have ER-low, HER2-negative breast cancer, your doctor must determine that hormone therapy is not suitable for you
Who Cannot Join the Study?
Age below 18 years
Pregnancy or breastfeeding
History of severe allergic reactions to similar medications
Active brain metastases (cancer that has spread to the brain) that are not treated
Serious heart conditions, including heart failure or uncontrolled high blood pressure
Severe liver problems (liver function tests more than 3 times the normal limit)
Severe kidney problems (creatinine clearance less than 30 mL/min)
Active infections requiring treatment
Other types of cancer within the last 3 years (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
Major surgery within 4 weeks before starting the study
Current participation in other clinical trials
Inability to swallow oral medications
Any condition that, in the opinion of the study doctor, would make participation unsafe
Unable to follow study procedures or attend scheduled visits
Izalontamab Brengitecan (also known as iza-bren) is a new investigational medication being tested for treating breast cancer. It’s being studied as a potential treatment for patients who have breast cancer that has spread or cannot be removed by surgery.
Paclitaxel is a commonly used chemotherapy medication that works by stopping cancer cells from dividing and growing. It’s often used to treat various types of cancer, including breast cancer.
Nab-paclitaxel is a form of paclitaxel that is bound to protein particles, making it easier for the body to deliver the medication to cancer cells. It’s commonly used in treating breast cancer.
Capecitabine is an oral chemotherapy medication that the body converts into a substance that interferes with cancer cell growth. It’s used to treat various cancers, including breast cancer.
Carboplatin is a platinum-based chemotherapy medication that works by damaging the DNA of cancer cells, preventing them from multiplying. It’s often used in combination with other chemotherapy medications.
Gemcitabine is a chemotherapy medication that works by preventing cancer cells from making and repairing DNA, which stops them from growing and dividing. It’s commonly used in combination with other cancer treatments.
Breast cancer – A disease that starts when cells in the breast tissue begin to grow out of control. These abnormal cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The cancer typically begins either in the cells of the lobules, which are the milk-producing glands, or in the ducts that drain milk from the lobules to the nipple. Over time, cancer cells can invade nearby healthy breast tissue and make their way into the underarm lymph nodes. If cancer cells get into the lymph nodes, they then have a pathway into other parts of the body.
Triple-negative breast cancer – A specific type of breast cancer that lacks three common types of receptors known to fuel most breast cancer growth: estrogen receptors, progesterone receptors, and HER2 protein. This cancer tends to be more aggressive than other types of breast cancer. It develops from cells in the breast ducts and grows when abnormal cells divide rapidly. The disease affects breast tissue similarly to other types of breast cancer but has distinct biological characteristics.
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