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A Single Arm Phase 2 Study of Peri-Operative Immune Checkpoint Inhibition and Cryoablation in Women With Hormone Receptor-Negative, HER2-Negative Early Stage/Resectable Breast Cancer

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Trial Profile

A Single Arm Phase 2 Study of Peri-Operative Immune Checkpoint Inhibition and Cryoablation in Women With Hormone Receptor-Negative, HER2-Negative Early Stage/Resectable Breast Cancer

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 15 Feb 2024

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At a glance

  • Drugs Ipilimumab (Primary) ; Nivolumab (Primary) ; Pembrolizumab (Primary) ; Capecitabine; Olaparib
  • Indications Carcinoma; Early breast cancer; HER2 negative breast cancer; Triple negative breast cancer
  • Focus Therapeutic Use

    • Most Recent Events

    • 15 Sep 2023 The study protocol amended to add pembrolizumab as an alternative ICI option in treatment arms. Inclusion and exclusion criteria also changed for the same.
    • 06 Jun 2023 As of 2/14/21, 16/80 patients have been enrolled and treated with ipilimumab/nivolumab/cryo followed by breast surgery and adjuvant nivolumab, as per trial design presented at the 59th Annual Meeting of the American Society of Clinical Oncology.
    • 06 Jun 2023 Trial design presented at the 59th Annual Meeting of the American Society of Clinical Oncology.
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