The drug ixabepilone as a new treatment option for metastatic or recurrent breast cancer

Breast cancer (mammary carcinoma) is a malignant disease of the mammary gland tissue characterized by the uncontrolled proliferation of mammary gland cells. Treatment of the disease depends on numerous factors, such as the patient’s overall health, the tumor’s growth rate (Ki-67 index), the presence of detectable hormone receptors on the surface of the cancer cells (estrogen receptor-positive, progesterone receptor-positive), and the increased expression of the HER2 protein on the cells (HER2-positive). The stage of the disease is also relevant. In Stage 4, metastases are present, meaning the tumor has spread throughout the body. A cure is unlikely at this stage. The same applies if the disease has been successfully treated but becomes active again in the breast area (local recurrence). Various therapies are used in an attempt to “keep the disease in check” for as long as possible. Chemotherapy with taxanes or anthracyclines is one of the standard treatments for metastatic breast cancer or a recurrence. If the tumor does not respond to these therapies, the investigational drug ixabepilone could represent a new treatment option. This is also a chemotherapy drug that is already approved in the U.S. for metastatic and locally advanced breast cancer.

The goal of this Phase 2 study is to further investigate the efficacy and safety of treatment with ixabepilone in a selected group of patients.

All study participants will receive the same treatment, and the study is open-label. This means that both the medical staff and the study participants know which medication is being administered. Before treatment begins, a special test (Ixabepilone Drug Response Prediction) is performed to predict the response to treatment. Subsequently, only those study participants who achieved a probability of over 67% on the test will receive ixabepilone as an infusion on Day 1 of a 21-day cycle. The treatments and follow-up examinations as part of the study will take place over a period of up to one year, during which the efficacy of the therapy and the occurrence of side effects from the medication will be evaluated.

Women and men aged 18 and older with metastatic or recurrent breast cancer who have previously been treated with anthracyclines and taxanes are eligible to participate in this study.