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
Price :
$35
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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
- 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.