(Breast Cancer) Neoadjuvant Chemotherapy: Ipatasertib + Paclitaxel?
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On May 30, 2019, the medical journal "Annals of Oncology" published the results of a Phase 2 clinical trial evaluating the effectiveness and safety of AKT inhibitor Ipatasertib + Paclitaxel as neoadjuvant chemotherapy in patients with early-stage triple-negative breast cancer. The trial (FAIRLANE) was a double-blind, placebo-controlled study divided into an Ipatasertib + Paclitaxel group and a Placebo + Paclitaxel group. The primary endpoint was the pathological complete response (pCR) rate in all patients; secondary endpoints included verification of pCR rates in patients with PIK3CA/AKT1/PTEN gene alterations.
In the trial results, the primary endpoint showed pCR rates in all patients (N=151) were 16% for the Ipatasertib group and 13% for the placebo group. For patients with PIK3CA/AKT1/PTEN gene alterations (N=62), pCR rates were 18% for the Ipatasertib group and 12% for the placebo group.
Regarding safety, the incidence of adverse events was 32% in the Ipatasertib group and 16% in the placebo group. Among these, diarrhea occurred in 17% of the Ipatasertib group and 1% of the placebo group.
Based on these results, M. Oliveira concluded that in early-stage triple-negative breast cancer patients using AKT inhibitor Ipatasertib + Paclitaxel as neoadjuvant chemotherapy, the pathological complete response rate did not differ significantly from the placebo control group.
Source: FAIRLANE, a double-blind placebo-controlled randomized phase II trial of neoadjuvant ipatasertib plus paclitaxel for early triple-negative breast cancer (Ann Oncol. 2019 May 30. pii: mdz177. doi: 10.1093/annonc/mdz177.)
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