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A Phase I/II Multicenter Study of the Combination of AZD2014 and Palbociclib on a Background of Hormonal Therapy in Patients With Locally Advanced/Metastatic Estrogen Receptor Positive Breast Cancer Comprising a Safety, Pharmacokinetic and Preliminary Efficacy Evaluation Followed by a Randomised, Double-Blind, Placebo-controlled, Parallel Group Extension

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A Phase I/II Multicenter Study of the Combination of AZD2014 and Palbociclib on a Background of Hormonal Therapy in Patients With Locally Advanced/Metastatic Estrogen Receptor Positive Breast Cancer Comprising a Safety, Pharmacokinetic and Preliminary Efficacy Evaluation Followed by a Randomised, Double-Blind, Placebo-controlled, Parallel Group Extension

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 07 Dec 2023

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At a glance

  • Drugs Vistusertib (Primary) ; Fulvestrant; Palbociclib
  • Indications Advanced breast cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms PASTOR
  • Sponsors AstraZeneca

Most Recent Events

  • 04 Dec 2023 Status changed from active, no longer recruiting to completed.
  • 19 Jan 2023 Planned End Date changed from 30 Dec 2022 to 29 Dec 2023.
  • 25 Jul 2022 The trial design changed from randomized and double-blind to open-label and non-randomized. Part C was to be a Phase 2, randomized, double-blind, extension comparing the triplet and doublet combinations. This dose finding/extension study was designed originally to consist of three parts: part C was deleted from the protocol and was not performed.

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