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    Association details:
    Biomarker:HER-2 overexpression
    Cancer:HER2 Positive Breast Cancer
    Drug:Herceptin (trastuzumab) (HER2 inhibitor) +
    Perjeta (pertuzumab) (HER2 dimerization inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2

    Excerpt:
    ...- Overexpression and/or amplification of HER2 in an invasive component of the core biopsy, according to one of the following definitions: •>30% of invasive tumor cells showing strong complete circumferential membrane staining (score 3+) •HER2 gene amplification defined as >6 HER2 gene copies per nucleus by in situ hybridization....
    Trial ID:
    TRAIN-2
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Pertuzumab, Trastuzumab, and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With HER2-Positive Advanced Breast Cancer

    Excerpt:
    ...- Patients must be diagnosed with metastatic cytologically or histologically confirmed adenocarcinoma of the breast with HER2 over-expression or with newly diagnosed locally advanced (including inflammatory) breast cancer (LABC) with stage II-III disease; patients with metastatic (stage IV) disease (MBC) must have measurable lesions...
    Trial ID:
    NCT01730833
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer

    Excerpt:
    ...HER2 overexpression or amplification will be based on local test results and is defined as either: (i) IHC staining of 3+ (uniform, intense membrane staining) in greater than or equal to 10% of invasive tumor cells or, (ii) Fluorescent in situ hybridization (FISH) result of more than six HER2 gene copies per nucleus or, (iii) FISH ratio (HER2 gene signals to chromosome 17 signals) of greater than or equal to 2.0....
    Trial ID:
    NCT01855828
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy

    Excerpt:
    ...Patients ≥ 18 years of age with histologically, and radiographically confirmed non-metastatic ER-positive (defined as ≥30% of positive cells) and HER2-positive (defined as overexpression by immunohistochemistry (3+) or 2+ and positive by defined by fluorescence or dual in situ hybridization.) breast cancer with minimal tumor size over 2 cm (≥T2 lesion) to receive neoadjuvant chemotherapy recommended by the treating physician 2....
    Trial ID:
    Neohttp
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Prospective Study of Breast Cancer Patients With Abnormal Strain Imaging

    Excerpt:
    ...Patients > 18 years of age with HER2-overexpressing early stage breast cancer (Stages I...
    Trial ID:
    NCT02993198
    Less C2 evidence
    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:
    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:

    Longer follow-up on clinical outcomes of weekly paclitaxel with trastuzumab and pertuzumab in patients with HER2 overexpressing metastatic breast cancer.

    Published date:
    05/16/2018
    Excerpt:
    HER2-positive MBC received 0 or 1 prior therapy received intravenous paclitaxel (80 mg/m2 weekly) with trastuzumab (8 mg/kg loading dose followed by 6 mg/kg every 3 weeks) and pertuzumab (840 mg loading dose followed by 420 mg every 3 weeks),...The median PFS was 24.2 months (95 % CI 17-35) for overall population; it was 25.7 months (95 % CI 17.0-NR) and 20.1 months (95 % CI 8.5-33.0) for patients with 0 and 1 prior treatment, respectively...With a longer follow-up of almost 5 years, combination of weekly paclitaxel, trastuzumab, and pertuzumab remains effective with a favorable median PFS...
    Secondary therapy:
    bisphosphonate bound paclitaxel
    DOI:
    10.1200/JCO.2018.36.15_suppl.e13005
    Trial ID:
    NCT01276041
    Evidence Level:
    Sensitive: D – Preclinical
    Source:
    Cancer Chemother Pharmacol
    Title:

    Combination efficacy of pertuzumab and trastuzumab for trastuzumab emtansine-resistant cells exhibiting attenuated lysosomal trafficking or efflux pumps upregulation

    Published date:
    09/30/2020
    Excerpt:
     The results suggest that the TRAS + PER combination may be effective in T-DM1-resistant cancer cells where HER2 overexpression is maintained.
    DOI:
    10.1007/s00280-020-04138-5