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A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-B49)

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A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-B49)

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

Latest Information Update: 11 Apr 2024

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At a glance

  • Drugs Pembrolizumab (Primary) ; Capecitabine; Doxorubicin liposomal; Glucose; Paclitaxel
  • Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Therapeutic Use
  • Acronyms KEYNOTE-B49; MK-3475-B49/KEYNOTE-B49
  • Sponsors Merck Sharp & Dohme Corp.

    • Most Recent Events

    • 01 Mar 2024 Status changed from recruiting to active, no longer recruiting.
    • 08 Feb 2023 Planned End Date changed from 21 Oct 2027 to 21 Jul 2028.
    • 08 Feb 2023 Planned primary completion date changed from 21 Oct 2027 to 21 Jul 2028.

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