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    Association details:
    Biomarker:HR positive
    Cancer:HER2 Negative Breast Cancer
    Drug:everolimus (mTOR inhibitor) +
    Kisqali (ribociclib) (CDK4 inhibitor, CDK6 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Clin Cancer Res
    Title:

    Phase I/II Trial of Exemestane, Ribociclib, and Everolimus in Women with HR+/HER2- Advanced Breast Cancer after Progression on CDK4/6 Inhibitors (TRINITI-1)

    Published date:
    06/18/2021
    Excerpt:
    ...ribociclib 200 mg, everolimus 5 mg, and exemestane 25 mg (group 2). CBR among 95 efficacy-evaluable patients (phases I and II) at week 24 was 41.1% (95% confidence interval, 31.1–51.6), which met the primary endpoint (predetermined threshold: 10%)...Preliminary TRINITI-1 safety and efficacy results support further investigation of CDK4/6 blockade and targeting of the PI3K/AKT/mTOR signaling pathway in patients with ET-refractory HR+/HER2− ABC after progression on a CDK4/6i.
    DOI:
    10.1158/1078-0432.CCR-20-2114
    Trial ID:
    TRINITI-1
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Clin Cancer Res
    Title:

    Phase 1b Dose Escalation/Expansion Trial of Ribociclib in Combination With Everolimus and Exemestane in Postmenopausal Women With HR+, HER2- Advanced Breast Cancerq

    Published date:
    09/30/2020
    Excerpt:
    Triplet therapy with endocrine therapy and mTOR and CDK4/6 inhibition provides clinical benefit and an acceptable safety profile in previously treated postmenopausal women with HR+, HER2- ABC.
    Secondary therapy:
    exemestane
    DOI:
    10.1158/1078-0432.CCR-20-1068