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A Phase 1b/2 Study of Safety and Efficacy of MLN0128 (Dual TORC1/2 Inhibitor) in Combination With Exemestane or Fulvestrant Therapy in Postmenopausal Women With ER+/HER2- Advanced or Metastatic Breast Cancer That Has Progressed on Treatment With Everolimus in Combination With Exemestane or Fulvestrant

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Trial Profile

A Phase 1b/2 Study of Safety and Efficacy of MLN0128 (Dual TORC1/2 Inhibitor) in Combination With Exemestane or Fulvestrant Therapy in Postmenopausal Women With ER+/HER2- Advanced or Metastatic Breast Cancer That Has Progressed on Treatment With Everolimus in Combination With Exemestane or Fulvestrant

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 13 Feb 2023

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At a glance

  • Drugs Sapanisertib (Primary) ; Exemestane; Fulvestrant
  • Indications Advanced breast cancer
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Takeda Oncology

    • Most Recent Events

    • 16 Dec 2021 This trial has been completed in France, according to European Clinical Trials Database record.
    • 05 Apr 2021 Following a protocol amendment to institute use of a new sapanisertib capsule containing milled active pharmaceutical ingredient, 6 patients were treated with milled sapanisertib 3 mg every day with exemestane or fulvestrant with no DLTs.
    • 05 Apr 2021 Results assessing the safety, tolerability and antitumour activity of sapanisertib in combination with exemestane or fulvestrant in 118 postmenopausal women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer.published in the Clinical Cancer Research
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