A Phase III clinical trial (last phase prior to FDA review) evaluating the investigative chemotherapy agent Myocet® (non-pegylated liposomal doxorubicin) in addition to standard therapy for HER2-positive breast cancer is now enrolling patients.
Metastatic breast cancer refers to cancer that has spread from its site of origin to distant sites in the body. Standard therapy for metastatic breast cancer often includes chemotherapy, with or without hormone therapy or targeted therapy. Doxorubicin is a commonly used chemotherapy agent in the treatment of breast cancer. However, side effects from doxorubicin can be severe, including irreversible damage to the heart.
Myocet is an investigational chemotherapy that contains the active form of doxorubicin but has been formulated to reduce side effects associated with the drug.
Twenty to thirty percent of breast cancers overexpress (make too much of) a protein known as HER2. Overexpression of this protein, referred to as HER2-positive cancer, leads to increased growth of cancer cells and a worse breast cancer prognosis. Trastuzumab (Herceptin®) is an agent that recognizes and binds to HER2-positive cells. The effects of trastuzumab are thought to include decreased cell growth and increased cell death.
Researchers are now enrolling patients with metastatic, HER2-positive breast cancer to further evaluate the effectiveness of Myocet. This trial will be directly comparing a standard treatment option consisting of trastuzumab plus paclitaxel to the combination of Myocet plus trastuzumab and paclitaxel as initial therapy for metastatic breast cancer. The goal of the trial is to determine if the addition of Myocet to standard therapy can improve anticancer responses among these patients.