This is a research study to test the safety and effectiveness of using the drug alpelisib
together with chemotherapy (nab-paclitaxel) and a drug called L-NMMA in patients with HER2
negative metastatic or locally advanced metaplastic breast cancer, who have not responded to
previous treatments.
Participants in this study in addition to the standard care chemotherapy will also receive
the drug alpelisib and L-NMMA. The therapies will be administered every 3 weeks (1 cycle)
until disease progression, toxicity or until the participant withdraws from the study. The
nab-paclitaxel chemotherapy will be administered intravenously on Day 1 of the 3 week cycles.
Participants will take the drug alpelisib by mouth once daily at a dose determined by a
safety study and the drug L-NMMA will be given intravenously on days 1 to 5 of the 3 week
cycles.