This study is examining the effectiveness of biological drug sacituzumab govitecan (IMMU-132) compared to standard treatments for patients with hormone receptor-positive metastatic breast cancer. The main outcomes that will be measured are cancer responsiveness to the drug and survival of patients without the cancer growing. This trial is recruiting in multiple locations in the United States.
Breast cancer can be caused by different mutations in a patients’ breast cells. The hormone receptor (HR; for estrogen or progesterone) and Human Epidermal Growth Factor Receptor 2 (HER2) are two such mutations. Available treatments often target one mutation but not the other. This means that they may not be effective for every patient.
Sacituzumab govitecan is an experimental biological treatment. It is made up of an antibody-drug which attaches onto the breast cancer cells and a second drug which kills the cancer cells. It may help patients who have not had success with other breast cancer treatments and have developed metastatic cancer (cancer that has spread to other parts of the body).
This study is examining the effectiveness of sacituzumab govitecan compared to standard treatments for patients with hormone receptor-positive metastatic breast cancer. The main outcomes of this study will be cancer responsiveness to the drug and survival without cancer growing or spreading.
Who are they looking for?
This study is recruiting 400 patients with metastatic breast cancer. Patients must have HR-positive and HER2-negative cancer. Patients must have cancer that did not respond to treatment or returned after at least 2 types of previous treatment. Patients must have previously received at least one hormonal and anti-metastases treatment. Patients must be eligible to receive one of the following chemotherapy treatments: eribulin (Halaven), capecitabine (Xeloda), gemcitabine (Gemzar) or vinorelbine (Navelbine). Patients must have adequate bone marrow, kidney, and liver function. Female patients must not be pregnant or breastfeeding.
Patients who received topoisomerase 1 inhibitor drugs previously cannot participate. Patients with a history of heart problems or Gilbert’s disease cannot participate. Patients with ongoing infections cannot participate. Patients allergic to the components of sacituzumab govitecan cannot participate.
How will it work
Patients will be divided into 2 groups. The first group will receive sacituzumab govitecan. The second group will receive one of the following chemotherapy drugs, as decided by their physician: eribulin, capecitabine, gemcitabine or vinorelbine.
Patient’s survival without the cancer growing and the response of cancer to the treatment will be measured for 3 years. The duration of cancer response to treatment will be measured for 3 years. Survival of patients will be measured for 4 years.