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    Association details:
    Biomarker:HER-2 overexpression
    Cancer:HER2 Positive Breast Cancer
    Drug:Herceptin (trastuzumab) (HER2 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    Therapeutic Goods Administration
    Excerpt:
    HERCEPTIN SC is indicated for the treatment of HER2-positive locally advanced breast cancer...in combination with neoadjuvant chemotherapy followed by adjuvant HERCEPTIN
    Secondary therapy:
    Aromatase inhibitor
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Clin Cancer Res
    Title:

    Biomarker Data From the Phase III KATHERINE Study of Adjuvant T-DM1 Versus Trastuzumab for Residual Invasive Disease After Neoadjuvant Therapy for HER2-Positive Breast Cancer

    Published date:
    02/02/2023
    Excerpt:
    CONTRADICTING EVIDENCE: In KATHERINE, adjuvant T-DM1 reduced risk of disease recurrence or death by 50% compared with trastuzumab in patients with residual invasive breast cancer...High versus low HER2 gene expression in residual disease was associated with worse outcomes with trastuzumab (HR, 2.02; 95% confidence interval [CI], 1.32–3.11)...
    DOI:
    https://doi.org/10.1158/1078-0432.CCR-22-1989
    Trial ID:
    KATHERINE
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    National Surgical Adjuvant Study of Breast Cancer(N-SAS BC) 07 [RESPECT]

    Excerpt:
    ...Primary region is HER 2 positive: either 3+ overexpression by IHC or positive by FISH 5....
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    The diagnosis and treatment of patients with HER2-positive breast cancer

    Excerpt:
    ...1) We required patients to have an Eastern Cooperative Oncology Group performance status of 0~2; 2) HER2（+++）or FISH:HER2 over-expression; 3) Survival time > 3 months; 4) Important viscera function is basically normal, Blood routine and liver and kidney function basically normal, no treatment taboo card....
    Trial ID:
    ChiCTR1800017467
    More C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ecancer
    Title:

    The benefits of trastuzumab in the treatment of HER2+ breast cancer as a function of exposure time

    Published date:
    01/20/2022
    Excerpt:
    The median time of survival (50%) was achieved only for patients with up to 63 days/no exposure to Trastuzumab regarding DFS (133.23 months)….The administration of trastuzumab improves survival in non-metastatic breast cancer patients, and is the main therapy for managing HER2-positive overexpressing/amplified tumours.
    DOI:
    https://doi.org/10.3332/ecancer.2022.1347
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    SABCS 2020
    Title:

    Termination of trastuzumab-based treatment after complete response in HER2-positive metastatic breast cancer

    Published date:
    11/17/2020
    Excerpt:
    ...patients with HER2 positive metastatic breast cancer received long-term trastuzumab...All patients had a pathological HER2 overexpressed tumor that scored 3+ (71.3%) by immunohistochemistry (IHC) or scored 2+ (28.7%) by IHC confirmed with FISH...A complete response was detected at 60 (75%) of the patients....After termination of trastuzumab, at a median follow-up 44.7 months (range, 11.6-66.6), recurrence was not detected in the patients...
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    SSO 2020
    Title:

    P55: The Degree of HER2 Protein Overexpression and Gene Amplification is Associated with the Extent of Response to Neoadjuvant Therapy

    Published date:
    08/17/2020
    Excerpt:
    In addition to standard chemotherapy, 105 patients (66%) received neoadjuvant Trastuzumab/Pertuzumab dual therapy, 47 (29%) received Trastuzumab alone...For patients with HER2+ breast cancer who undergo NAT, the degree of HER2 protein overexpression and gene amplification were associated with response to NAT.
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2018
    Title:

    Intrinsic subtypes of HER2-positive breast cancer and their associations with pathologic complete response (pCR) and outcomes: Findings from NSABP B-41, a randomized neoadjuvant trial.

    Published date:
    05/16/2018
    Excerpt:
    In HER2-E, patients on trastuzumab-based arms had higher pCR than those on the lapatinib arm (67% vs 49%, p = 0.02).
    DOI:
    10.1200/JCO.2018.36.15_suppl.580
    Trial ID:
    NSABP B-41