Metastatic TNBC: ipatasertib extends PFS benefit of front-line paclitaxel

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  • In patients with metastatic triple-negative breast cancer (TNBC), median PFS is prolonged who received the novel drug ipatasertib plus paclitaxel (Abraxane) vs placebo plus paclitaxel.
Why this matters
  • Because metastatic TNBC has a poor prognosis, this phase 2 trial offers hope for a new class of drug, AKT inhibitors, and warrants further study in a phase 3 trial.
Study design
  • In this randomized, placebo-controlled, double-blind, phase 2 trial, 124 patients were randomly assigned to paclitaxel (80 mg/m2) plus ipatasertib (400 mg) or paclitaxel plus placebo every 28 d until disease progression or unacceptable toxicity.
  • Funding: F. Hoffmann-LaRoche.
Key results
  • The ipatasertib group had longer median PFS of 6.2 mo vs 4.9 mo with placebo (HR, 0.60; P=.037).
  • 23% of the ipatasertib group had diarrhea as a grade 3 or worse adverse event vs 0% of the placebo group.
  • 28% of the ipastasertib group had serious adverse events vs 15% of the placebo group.
  • Relatively small sample sizes.