A Phase Ib/II, Multicenter Study of the Combination of LEE011 and BYL719 With Letrozole in Adult Patients With Advanced ER+ Breast Cancer

Trial Profile

A Phase Ib/II, Multicenter Study of the Combination of LEE011 and BYL719 With Letrozole in Adult Patients With Advanced ER+ Breast Cancer

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 29 Sep 2017

At a glance

  • Drugs Alpelisib (Primary) ; Ribociclib (Primary) ; Letrozole
  • Indications Advanced breast cancer
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Novartis Pharmaceuticals
  • Most Recent Events

    • 24 Jul 2017 Planned primary completion date changed from 31 May 2019 to 30 Apr 2019.
    • 14 Jun 2017 Planned number of patients changed from 225 to 253.
    • 05 Apr 2017 Results of a pooled analysis assessing preliminary clinical activity in patients from three clinical trials (NCT01872260, NCT01857193 and NCT02088684), presented at the 108th Annual Meeting of the American Association for Cancer Research
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