A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer

Exclusion Criteria

• •Pregnant or breastfeeding, or intending to become pregnant
• •Prior treatment with fulvestrant or other selective estrogen receptor down-regulator
• •Prior treatment with PI3K inhibitor, mTOR inhibitor or AKT inhibitor
• •Phase III only: Prior treatment with CDK4/6 inhibitor for locally advanced unresectable or metastatic breast cancer
• •Prior treatment with a cytotoxic chemotherapy regimen for metastatic breast cancer
• •History of Type I or Type II diabetes mellitus requiring insulin
• •History of or active inflammatory bowel disease or active bowel inflammation
• •Lung disease: pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, Aspergillosis, active tuberculosis, or history of opportunistic infections