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A National Phase IIIb, Multi-center, Open Label Study for Women and Men With Hormone-receptor Positive, HER-2 Negative Locally Advanced or Metastatic Breast Cancer Treated With Ribociclib (LEE011) in Combination With Letrozole

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A National Phase IIIb, Multi-center, Open Label Study for Women and Men With Hormone-receptor Positive, HER-2 Negative Locally Advanced or Metastatic Breast Cancer Treated With Ribociclib (LEE011) in Combination With Letrozole

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Jan 2024

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At a glance

  • Drugs Letrozole (Primary) ; Ribociclib (Primary) ; Goserelin
  • Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms RIBECCA
  • Sponsors Novartis Pharmaceuticals

    • Most Recent Events

    • 15 Dec 2023 Final Results published in the European Journal of Cancer
    • 10 Dec 2022 Results of AI4ANNA study assessing the predictive potential of machine learning methods with respect to tumor control and safety outcomes using German study data (RIBECCA; n=487, RIBANNA; n=1904) and toidentify the most relevant baseline factors for prediction, presented at the 45th Annual San Antonio Breast Cancer Symposium.
    • 22 Dec 2021 Results (n=40) of preplanned exploratory subanalysis investigating peripheral immune responses to ribociclib in patients with metastatic HR+ breast cancer, published in the European Journal of Cancer

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