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    Association details:
    Biomarker:ER mutation
    Cancer:HER2 Negative Breast Cancer
    Drug:Ibrance (palbociclib) (CDK4 inhibitor, CDK6 inhibitor)
    Drug Class:Aromatase inhibitor
    Direction:Resistant
    Evidence:
    Evidence Level:
    Resistant: B - Late Trials
    Source:
    AACR 2021
    Title:

    CT189 - Characterization of ESR1 mutations at metastatic relapse and outcome under first line aromatase inhibitor and palbociclib in the PADA-1 trial

    Published date:
    03/10/2021
    Excerpt:
    PADA-1 (NCT03079011) is a phase III trial testing the clinical utility of real time ESR1mut detection in the blood of patients treated with AI-Pal. Main inclusion criteria are patients with ER+ HER2- MBC...Presence of ESR1mut detected in cfDNA at metastatic relapse are associated with a shorter PFS under first line AI and palbociclib.
    Trial ID:
    PADA-1
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection

    Excerpt:
    ...- Hematological safety of patients with bone metastases will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.- Progression-Free Survival (PFS) will be measured from the time of randomization (following rising ESR1 mutation detection) to the time of tumor progression (as assessed by the investigator per RECIST v1.1) or death (whichever comes first) – in randomized patients....
    Trial ID:
    2016-004360-18
    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
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection

    Excerpt:
    ...Incidence of treatment-emergent Adverse Events`To assess whether a change of the hormone therapy associated with palbociclib will benefit patients for whom rising ESR1 mutations are detected during treatment with palbociclib and aromatase inhibitor. ...
    Trial ID:
    PADA-1
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors

    Excerpt:
    ...ESR1 mutational status will be blinded to the patients, investigators and study team.`...
    Trial ID:
    PEARL