BREAST: METASTATIC: TNBC: 1st Line: IPATUNITY-170

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.

Title
Hoffmann-La Roche CO41101 (1st line TNBC- IPATUNITY-170)
Study Title

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.

Site Link
Malignancy
Breast, TNBC, Triple negative breast cancer
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st Line
Investigational Agent
Ipatasertib, atezolizumab, paclitaxel
Drug Class
PI3-kinase inhibitor, PD-L1 inhibitor, taxane
PI
Greg Vidal, MD, PhD
Sponsor
Hoffmann-La Roche
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • 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 </=150 and HgbA1c </= 7.5%, ALT/AST </= 2.5x ULN
    • PT/PTT </= 1.5x ULN
  • 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
Objective
  • 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
Assessment Frequency
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Assessment Frequency 2
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Assessment Frequency Link
Path
ER negative, PR negative, HER2 negative adenocarcinoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
X