Last updated on November 2019

A Study to Evaluate the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Breast Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Adequate hematologic and organ function
  • Life expectancy of at least 6 months
  • For men and women of child bearing potential: agreement to remain abstinent or use protocol defined contraceptive measures during the treatment period and for at least 28 days after the last dose of ipatasertib, 6 months after the last dose of paclitaxel, and 5 months after the last dose of atezolizumab, whichever occurs later
  • Histologically documented TNBC that is locally advanced or metastatic
  • Measurable disease according to RECIST v1.1

Exclusion Criteria:

  • History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills
  • Active infection
  • History of or current evidence of HIV infection
  • Known clinically significant history of liver disease
  • Pregnant or breastfeeding
  • Left ventricular ejection fraction < 50%
  • Prior treatment with an Akt inhibitor
  • History of or known presence of brain or spinal cord metastases
  • Patients may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation treatment for early stage breast cancer, provided all chemotherapy was completed >= 12 months prior to Day 1 of Cycle 1
  • Uncontrolled tumor related complications
  • Malignancies other than breast cancer within 5 years prior to Day 1 of Cycle 1
  • History of Type I or Type II diabetes mellitus requiring insulin
  • Uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia
  • History of or active inflammatory bowel disease or active bowel inflammation
  • Clinically significant lung disease
  • Treatment with strong CYP3A inhibitors or strong CYP3A inducers
  • Active or history of autoimmune disease or immune deficiency
  • Prior allogeneic stem cell or solid organ transplantation
  • History of hypersensitivity reactions to study drug or any component of the study drug formulation
  • Treatment with systemic immunostimulatory agents and immunosuppressive medication treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study
  • Grade >= 2 peripheral neuropathy

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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