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A Phase III Randomized, Double-Blind, Neoadjuvant Study of Hormonal Therapy plus Palbociclib versus Hormonal Therapy plus Placebo in Women with Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer

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Trial Profile

A Phase III Randomized, Double-Blind, Neoadjuvant Study of Hormonal Therapy plus Palbociclib versus Hormonal Therapy plus Placebo in Women with Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Oct 2025

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At a glance

  • Drugs Palbociclib (Primary) ; Goserelin; Letrozole; Leuprorelin; Tamoxifen
  • Indications Early breast cancer; HER2 negative breast cancer
  • Focus Therapeutic Use

Most Recent Events

  • 09 Mar 2023 Status changed from active, no longer recruiting to completed.
  • 05 Jan 2022 Planned End Date changed from 1 Jun 2022 to 30 Jun 2022.
  • 21 Jun 2021 Planned primary completion date changed from 30 Nov 2021 to 30 Dec 2021.

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