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A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)

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Trial Profile

A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Feb 2024

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At a glance

  • Drugs Pembrolizumab (Primary) ; Carboplatin; Cyclophosphamide; Doxorubicin; Epirubicin; Filgrastim; Paclitaxel; Pegfilgrastim
  • Indications Advanced breast cancer; Early breast cancer; Male breast cancer; Triple negative breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms KEYNOTE-522
  • Sponsors Merck Sharp & Dohme

    • Most Recent Events

    • 24 Oct 2023 Updated Results (At data cutoff ; March 23, 2023) assessing efficacy of Pembrolizumab or placebo plus chemotherapy followed by pembrolizumab or placebo for early-stage TNBC presented at the 48th European Society for Medical Oncology Congress
    • 24 Oct 2023 Results assessing the cost-effectiveness of neoadjuvant pembrolizumab + chemotherapy [paclitaxel + carboplatin followed by anthracycline + cyclophosphamide] plus adjuvant pembrolizumab versus neoadjuvant chemotherapy in high-risk TNBC presented at the 48th European Society for Medical Oncology Congress
    • 06 Jun 2023 Results evaluating the the association between neoadjuvant pembrolizumab plus chemotherapy (NAC+P) compared to neoadjuvant chemotherapy alone (NAC), presented at the 59th Annual Meeting of the American Society of Clinical Oncology.
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