A Phase III, Double-blind, Placebo-controlled, Randomized Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer.

• Triple-negative adenocarcinoma of the breast either unresectable with curative intent and either locally advanced or metastatic 
  • Most recent biopsy shows ER and PR levels <1%, HER2 <3+
• No prior systemic therapy for metastatic disease
  • No chemotherapy for early disease in last 12 months
• Appropriate candidate for paclitaxel monotherapy if PD-L1 negative (or unknown)
• Appropriate candidate for paclitaxel and atezolizumab if PD-L1 status is positive
• Appropriate lab values
  • CBC: ANC >/= 1500, Hgb >/= 9, plts >/= 100
  • Chem: CrCl >/=50, Alb >/=3, Gluc
  • PT/PTT
• No known HIV/HBV/HCV
• No LVEF <50%
• No requirement for steroids >10mg prednisone or equivalent
• No known CNS disease or spinal cord mets
• No other malignancies in last 5 years except in-situ cervical, non-melanoma skin, or stage I endometrial
• No history of diabetes
• No Grade 2 or higher neuropathy
• No active or history of autoimmune disease

• Primary
  • PFS
  • OS
• Secondary
  • ORR
  • DOR
  • CBR
  • PRO
  • PFS in PD-L1 negative patients
  • OS in PD-L1 negative patients
  • ORR in PD-L1 negative patients
  • PFS in PIK3CA mt patients
  • OS in PIK3CA mt patients
  • ORR in PIK3CA mt patients
  • Safety
  • PK