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    Association details:
    Biomarker:HR positive
    Cancer:Hormone Receptor Positive Breast Cancer
    Drug:Kisqali (ribociclib) (CDK4/6 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    European Medicines Agency
    Published date:
    07/17/2015
    Excerpt:
    Kisqali is indicated for the treatment of women with hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
    Secondary therapy:
    fulvestrant; Aromatase inhibitor
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Eur J Cancer
    Title:

    Treatment with ribociclib shows favourable immunomodulatory effects in patients with hormone receptor-positive breast cancer—findings from the RIBECCA trial

    Published date:
    12/23/2021
    Excerpt:
    Here, we investigated peripheral immune responses to ribociclib in patients with metastatic HR+ breast cancer as a preplanned exploratory subanalysis of the RIBECCA trial….Profiling of peripheral immune cell subpopulations showed a decrease in Treg cell frequencies, which was associated with treatment response....We show that treatment with ribociclib has significant effects on the peripheral innate and adaptive immune response in patients with HR+ breast cancer.
    DOI:
    https://doi.org/10.1016/j.ejca.2021.11.025
    Trial ID:
    RIBECCA
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ESMO-BC-I 2020
    Title:

    144P - Patient-reported outcomes (PROs) in advanced breast cancer (ABC) treated with ribociclib (RIB) + fulvestrant (FUL) as first-line (1L) and second-line (2L) therapy in MONALEESA-3 (ML-3)

    Published date:
    05/24/2020
    Excerpt:
    These results, along with PFS and OS benefits observed with RIB, support use of RIB + FUL as 1L or 2L therapy to treat HR+/HER2− ABC.
    Secondary therapy:
    fulvestrant
    Trial ID:
    MONALEESA-3
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Cancer Treat Res
    Title:

    Cyclin-dependent kinase 4/6 inhibitors in combination with fulvestrant for previously treated metastatic hormone receptor-positive breast cancer patients: A systematic review and meta-analysis of randomized clinical trials

    Published date:
    05/04/2020
    Excerpt:
    To compare the efficacy and safety profile of the combination of cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors and fulvestrant versus fulvestrant alone in previously treated patients with advanced hormone-receptor positive breast cancer. Use of abemaciclib, palbociclib, or ribociclib in combination with fulvestrant was significantly associated with longer PFS compared to use of fulvestrant alone...
    Secondary therapy:
    fulvestrant
    DOI:
    10.1016/j.ctarc.2020.100175
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Comparison of Clinical Efficacy Between Letrozole + Ribociclib and Fulvestrant + Letrozole + Ribociclib in Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer

    Excerpt:
    ...- Histologically confirmed unresectable, locally advanced or metastatic invasive breast cancer with hormone receptor positive/HER2 negative...
    Trial ID:
    NCT05816655
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Ribociclib-endocrine Combination Therapy Versus Chemotherapy as 1st Line in Visceral mBC

    Excerpt:
    ...- Histologically or cytologically confirmed diagnosis of HR-positive (ER+ ≥10%), HER2-negative advanced stage breast cancer...
    Trial ID:
    SAKK 21/18
    More C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ESMO-BC-I 2020
    Title:

    32P - The neutrophil-to-lymphocyte and platelet-to-lymphocyte ratios predict efficacy of CDK 4/6 inhibitors in women with hormone receptor-positive/HER2-negative advanced breast cancer

    Published date:
    05/23/2020
    Excerpt:
    CONTRADICTING EVIDENCE: This is the first study to show a significant association between high NLR or PLR values, as measured during CDK 4/6 inhibitor treatment, and lower PFS in HR+ aBC pts.