A Phase I/II, Single Arm, Open-label Study of Ribociclib in Combination With Everolimus + Exemestane in the Treatment of Men and Postmenopausal Women With HR+, HER2- Locally Advanced or Metastatic Breast Cancer Following Progression on a CDK 4/6 Inhibitor

Trial Profile

A Phase I/II, Single Arm, Open-label Study of Ribociclib in Combination With Everolimus + Exemestane in the Treatment of Men and Postmenopausal Women With HR+, HER2- Locally Advanced or Metastatic Breast Cancer Following Progression on a CDK 4/6 Inhibitor

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 09 Dec 2017

At a glance

  • Drugs Everolimus (Primary) ; Exemestane (Primary) ; Ribociclib (Primary)
  • Indications Advanced breast cancer; Male breast cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms TRINITI-1
  • Sponsors Novartis Pharmaceuticals
  • Most Recent Events

    • 09 Dec 2017 Results from phase I part of the study (n=17) describing efficacy and updated PK and safety, presented at the 40th Annual San Antonio Breast Cancer Symposium.
    • 14 Nov 2017 According to a Novartis media release, data from this trial will be presented at the upcoming 40th annual San Antonio Breast Cancer Symposium (SABCS).
    • 05 Apr 2017 Results of phase I (n=17) assessing tolerability and pharmacokinetics, presented at the 108th Annual Meeting of the American Association for Cancer Research
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