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    Association details:
    Biomarker:ESR1 mutation
    Cancer:Estrogen Receptor Positive Breast Cancer
    Drug:Ibrance (palbociclib) (CDK4 inhibitor, CDK6 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    The Oncologist
    Title:

    Early Switch to Fulvestrant Plus Palbociclib Improves Outcomes in ESR1-Mutated, Estrogen Receptor-Positive Metastatic Breast Cancer

    Published date:
    03/28/2022
    Excerpt:
    The median PFS for patients who were switched to fulvestrant was 11.9 months, compared with 5.7 months for patients who remained on an aromatase inhibitor (HR, 0.61; p =.005)….Findings from the PADA-1 trial support a personalized approach to treatment modification based on the early detection of ESR1 mutations in patients with ER-positive metastatic breast cancer.
    Secondary therapy:
    fulvestrant
    DOI:
    https://doi.org/10.1093/oncolo/oyac016
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Phase I Clinical Trial of FWD1802 in Patients With ER+/HER2- BC.

    Excerpt:
    ...Provision of blood sample to test ESR1 mutation status and for other biomarker assessment....
    Trial ID:
    NCT06064812
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of GDC-0810 Single Agent or in Combination With Palbociclib and/or a Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer

    Excerpt:
    ...confirmed estrogen receptor alpha (ESR1) mutation and presence of measurable disease as per RECIST v1.1 or evaluable bone disease...
    Trial ID:
    NCT01823835