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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

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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

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 15 Feb 2022

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At a glance

  • Drugs Everolimus (Primary) ; Exemestane (Primary) ; Ribociclib (Primary)
  • Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms TRINITI-1
  • Sponsors Novartis Pharmaceuticals

Most Recent Events

  • 15 Mar 2021 Primary endpoint has been met. (Phase II: Clinical Benefit Rate (CBR) among subjects receiving triplet therapy), as per results published in the Clinical Cancer Research
  • 15 Mar 2021 Results of interim efficacy, safety and exploratory biomarker of exemestane, ribociclib, and everolimus in advanced breast cancer, published in the Clinical Cancer Research
  • 03 May 2020 Status changed from active, no longer recruiting to completed.

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