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    Association details:
    Biomarker:HER-2 positive
    Cancer:HER2 Positive Breast Cancer
    Drug:trastuzumab rezetecan (SHR-A1811) (Topoisomerase I inhibitor, HER2-targeted antibody-drug conjugate)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases

    Excerpt:
    ...Pathologically confirmed HER2-positive or HER2-low advanced breast cancer; 3....
    Trial ID:
    NCT05769010
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer

    Excerpt:
    ...HER2 positive (IHC3+ or ISH+) unresectable or metastatic breast cancer confirmed by histology or cytology....
    Trial ID:
    NCT06057610
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Different Targeted Antibody-drug Conjugates For HER2 Ultra-low or No Expression Advanced Breast Cancer（GALAXY）

    Excerpt:
    ...was never previously HER2-positive (IHC 3+ or ISH+) At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1....
    Trial ID:
    GALAXY
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Trial of SHR-A1811versus Pyrotinib in Combination With Capecitabine in HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane

    Excerpt:
    ...Unresectable or metastatic HER2 positive breast cancer previously treated with Trastuzumab and Taxane in recurrence and metastasis stage; 3....
    Trial ID:
    NCT05424835
    Less C2 evidence
    Evidence Level:
    Sensitive: D – Preclinical
    Source:
    Cancer Res
    Title:

    Abstract CT175: Safety, tolerability, pharmacokinetics, and antitumor activity of SHR-A1811 in HER2-expressing/mutated advanced solid tumors: A global phase 1, multi-center, first-in-human study

    Published date:
    04/14/2023
    Excerpt:
    Pts were eligible if they had HER2 positive breast cancer (BC), HER2 positive gastric/GEJ carcinoma, HER2 low-expressing BC, HER2-expressing/mutated NSCLC, or other HER2-expressing/mutated solid tumors, and were refractory or intolerant to standard therapy....Objective responses were observed in pts with HER2 positive BC (88/108, ORR 81.5%, 95% CI 72.9-88.3), HER2-low BC (43/77, ORR 55.8%, 95% CI 44.1-67.2), urothelial carcinoma (7/11), colorectal cancer (3/10), gastric/GEJ carcinoma (5/9), biliary tract cancer (5/8), NSCLC (1/3), endometrial cancer (1/2), and H&N cancer (1/1)....SHR-A1811 was well-tolerated and showed promising antitumor activity in heavily pretreated advanced solid tumors.
    DOI:
    https://doi.org/10.1158/1538-7445.AM2023-CT175