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    Association details:
    Biomarker:HER-2 overexpression
    Cancer:Urothelial Cancer
    Drug:Herceptin (trastuzumab) (HER2 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C1 - Off-label
      (Approved for Gastric Cancer)
    New
    Excerpt:
    Herceptin should only be used in patients with metastatic gastric cancer whose tumours have HER2 overexpression...
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Phase II clinical trial of Cisplatin, Gemcitabine and Trastuzumab (Herceptin®) as first line treatment of advanced irresectable transitional-cell urothelial carcinoma with overexpression of C-erbB-2

    Excerpt:
    ...- Histologically proven diagnosis of urothelial adenocarcinoma of bladder, ureter and renal pelvis with overexpression of C-erbB-2 determined by IHC (+++) or FISH/CISH (in IHC ++) - Non-resectable metastasic or locally advanced disease at the time of inclusion. ...
    Trial ID:
    2004-005241-36
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Efficacy of Combination of Trastuzumab to Gemcitabine - Platinum Advanced or Metastatic Urothelial Carcinoma

    Excerpt:
    ...- Tumor and / or metastasis overexpressing HER2 immunohistochemistry (IHC 3 +) or IHC 2 + and FISH +....
    Trial ID:
    CVH-CT02
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Herceptin (Trastuzumab) Combination Therapy in Patients With Metastatic Urothelial Cancer

    Excerpt:
    ...- HER2 overexpression (IHC [2+] or [3+])....
    Trial ID:
    NCT02006667
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Trastuzumab (Herceptin), Paclitaxel, Carboplatin and Gemcitabine in Advanced Urothelial Cancer

    Excerpt:
    ...- If the available tissue is from the primary tumor and is HER2 negative and if the serum is negative, to qualify for the study a biopsy of a metastatic site should be done and the patient will be eligible ONLY if this demonstrates HER2 over-expression....
    Trial ID:
    NCT00151034
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Herceptin (Trastuzumab) Monotherapy in Patients With Metastatic Urothelial Cancer

    Excerpt:
    ...- HER2 overexpression (IHC [2+] or [3+])....
    Trial ID:
    NCT02013765
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Trastuzumab and Combination Chemotherapy in Treating Patients With Locally Recurrent or Metastatic Urinary Tract Cancer

    Excerpt:
    ...patients must have HER2 overexpression as documented by...
    Trial ID:
    NCT00005831
    Less C2 evidence
    Evidence Level:
    Sensitive: C4 – Case Studies
    New
    Source:
    J Natl Compr Canc Netw
    Title:

    Oncogenic Addiction to ERBB2 Signaling Predicts Response to Trastuzumab in Urothelial Cancer

    Excerpt:
    We found a strikingly high ERBB2 mRNA expression and enrichment of downstream oncogenic ERBB2 signaling in this patient's tumors compared with tumors from an unselected group of patients with UC (N=17). This patient had an exceptional sustained response to trastuzumab. Our findings show that oncogenic addiction to ERBB2 signaling potentially predicts response to ERBB2-directed therapy of UC.
    DOI:
    10.6004/jnccn.2018.7264