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FAIRLANE study results presented at AACR

FAIRLANE study results presented at AACR

18 Apr 2018

The preliminary results of Phase II FAIRLANE (NCT02301988) study have been presented at the American Association for Cancer Research (AACR) meeting. The aim of this study is to investigate the efficacy and safety of ipatasertib, an AKT inhibitor, in combination with paclitaxel chemotherapy as neoadjuvant therapy once per week for patients with early triple-negative breast cancer.

Based on conclusions presented in the oral session by Mafalda Oliveira M.D., one of the PIs of the study and member of the Board of Directors of SOLTI, the addition of ipatasertib could benefit triple-negative breast cancer patients, with a higher anti-tumor effect observed in biomarker-selected patients with PIK3CA/AKT1/PTEN-altered tumors. In a previous study, LOTUS (NCT02162719), this option has shown greater benefit in biomarker positive patients. This clinical trial evaluated the same combination in metastatic patients.

FAIRLANE safety data are consistent with those observed in previous studies.

This study is aligned with SOLTI's commitment to participate in proof-of-concept clinical trials and to research biomarkers for new drugs development.

FAIRLANE is a hypothesis-generating, exploratory study that has provided more information about ipatasertib in combination with paclitaxel in patients with early triple-negative breast cancer and builds on results from the LOTUS study. The conclusions of both studies support continued research of ipatasertib in combination with paclitaxel combination in patients with mutations in PIK3CA, AKT1 and PTEN.

In fact, the IPATunity130 (NCT03337724) phase III study is underway. This clinical trial evaluates ipatasertib and paclitaxel in first line treatment for patients with PIK3CA, AKT1 and PTEN-mutations, locally advanced or metastatic, either triple-negative or HER2-negative or hormone receptor-positive breast cancer. It has been designed based on data from FAIRLANE and LOTUS studies.

The FAIRLANE study, sponsored by Genentech, has had an outstanding participation of SOLTI, which has coordinated 20 hospitals and recruited more than 100 patients in Spain and Portugal.



  • Centro Integral Oncológico Clara Campal
  • Institut Català d’Oncologia - L’Hospitalet
  • Hospital Clínico Universitario de Valencia
  • Hospital Universitario Vall d’Hebron
  • Hospital Provincial de Castellón
  • Hospital Universitario Son Espases
  • Hospital Universitario Virgen del Rocío
  • Hospital Universitario Arnau de Vilanova de Lleida
  • Hospital Universitario 12 de Octubre
  • Complejo Hospitalario Universitario de Santiago de Compostela
  • Hospital Universitario San Pedro de Alcántara
  • Hospital Universitario Fundación Jiménez Díaz
  • Hospital Universitario Virgen Macarena
  • Hospital Universitario Son Llàtzer
  • Hospital Universitario Fundación Alcorcón
  • Hospital Universitario Rey Juan Carlos
  • MD Anderson Cancer Center Madrid
  • Institut Català d’Oncologia - Girona
  • Hospital Universitario Sant Joan de Reus
  • Hospital Universitario de Fuenlabrada


  • Hospital Beatriz Ângelo
  • Instituto Português Oncologia de Lisboa (IPO Lisboa)
  • Instituto Português Oncologia do Porto (IPO Porto)




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