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Trial Summary


Protocol No.TBCRC045
StatusOPEN TO ACCRUAL
Principal InvestigatorStorniolo, Anna
ScopeNational
PhasePhase II
Age GroupAdult
TitleA RANDOMIZED, PHASE II STUDY COMPARING TRASTUZUMAB AND VINORELBINE IN COMBINATION WITH AVELUMAB OR AVELUMAB AND UTOMILUMAB (41BB/CD137 AGONIST), IN PATIENTS WITH HER2-POSITIVE METASTATIC BREAST CANCER WHO HAVE PROGRESSED ON PRIOR TRASTUZUMAB AND PERTUZUMAB: The "AVIATOR Study
DescriptionThis research study is studying a combination of drugs as a possible treatment for breast cancer. The drugs involved in this study are: Group A: Trastuzumab (Herceptin) + Vinorelbine (Navelbine) Group B: Trastuzumab + Vinorelbine + Avelumab Group C: Trastuzumab + Vinorelbine + Avelumab + Utomilumab (PF-05082566).
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:
  • Histologically confirmed breast adenocarcinoma that is unresectable loco-regionally advanced or metastatic.
  • HER2-positive (immunohistochemistry score 3+) or ERBB2- amplification (Ratio ERBB2/centromeres ≥ 2.0 or mean gene copy number ≥ 6) on primary tumor or of metastatic or unresectable loco-regional biopsy.
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesBreast
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactPhone: (317) 278-5632
    Email: iutrials@iu.edu