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    Association details:
    Biomarker:ER positive
    Cancer:HER2 Positive Breast Cancer
    Drug:sacibertinib (Hemay022) (EGFR inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    Study Evaluating Hemay022 in Combination With Endocrine Therapy In Subjects With ER Positive and HER2 Positive Advanced Breast Cancer

    Excerpt:
    ...ER positive (≥1%) and HER2 over-expression (immunohistochemical IHC test 3+ and/or in situ hybridization ISH test positive), Post-menopausal female subjects who are suitable for exemestane as endocrine therapy ;...
    Trial ID:
    NCT03308201
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    SABCS 2023
    Title:

    Antitumor activity and safety of sacibertinib (Hemay022) in combination with endocrine therapy in patients with ER and HER2 both positive metastatic breast cancer: A phase Ib study

    Published date:
    12/02/2023
    Excerpt:
    In the 500 mg Sacibertinib plus exemestane cohort (N = 12), ORR was 25.0%(3/12), DCR was 100.0%(12/12), CBR was 50.0%(6/12), and median PFS was 9.0 months. Sacibertinib plus endocrine therapy had a favorable safety profile and antitumor activity in patients with ER+/ HER2+ MBC, 400-500mg daily showed more efficacy, supporting further assessment in randomized studies.
    Secondary therapy:
    exemestane
    Trial ID:
    NCT03308201