Triple-negative breast cancers do not express the HER2 protein nor contain estrogen or progesterone receptors. They can be challenging to treat. Doctors are therefore seeking more effective therapies for this disease.
The purpose of this study is to see if combining paclitaxel with LCL161 is more effective for treating triple-negative breast cancer than paclitaxel alone. LCL161 is an investigational drug that works by releasing the brakes on cell death. All normal cells undergo a process called “apoptosis,” or programmed cell death, but cancer cells lack this feature. LCL161 is designed block the inhibitors of apoptosis so cancer cells can die.
In prior laboratory studies, LCL161 and paclitaxel caused more cancer cells to die than paclitaxel given alone. LCL161 has also caused triple-negative breast cancer cells to die.
Patients in this study will be randomly assigned to receive LCL161 plus paclitaxel, or paclitaxel alone. Paclitaxel is given intravenously (by vein), while LCL161 is taken orally (by mouth). Researchers will also compare patients’ responses to therapy with the “genetic signatures” of their tumors.