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A Double-Blind, Placebo-Controlled, Randomized Phase III Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Patients With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

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Trial Profile

A Double-Blind, Placebo-Controlled, Randomized Phase III Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Patients With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Mar 2024

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At a glance

  • Drugs Ipatasertib (Primary) ; Paclitaxel
  • Indications Adenocarcinoma; Advanced breast cancer; HER2 negative breast cancer; Male breast cancer; Triple negative breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms IPATunity130
  • Sponsors Chugai Pharmaceutical; Roche; Roche Farma
  • Most Recent Events

    • 07 Dec 2023 Results from NCT03800836, NCT03337724 and NCT04177108 ; evaluating a triplet regimen combining immune checkpoint blockade, AKT pathway inhibition, and (nab)paclitaxel as first-line therapy for locally advanced/metastatic triple-negative breast cancer published in the Clinical Cancer Research
    • 07 Feb 2023 Status changed from active, no longer recruiting to completed.
    • 12 Jan 2023 Planned End Date changed from 22 Dec 2022 to 31 Jan 2023.
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