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A Randomized, Multicenter, Double-blind Phase 3 Study Of Pd-0332991 (Oral Cdk 4/6 Inhibitor) Plus Letrozole Versus Placebo Plus Letrozole For The Treatment Of Postmenopausal Women With Er (+), Her2 (-) Breast Cancer Who Have Not Received Any Prior Systemic Anti Cancer Treatment For Advanced Disease

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Trial Profile

A Randomized, Multicenter, Double-blind Phase 3 Study Of Pd-0332991 (Oral Cdk 4/6 Inhibitor) Plus Letrozole Versus Placebo Plus Letrozole For The Treatment Of Postmenopausal Women With Er (+), Her2 (-) Breast Cancer Who Have Not Received Any Prior Systemic Anti Cancer Treatment For Advanced Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Nov 2024

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At a glance

  • Drugs Palbociclib (Primary) ; Letrozole
  • Indications Adenocarcinoma; Advanced breast cancer; HER2 negative breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms PALOMA-2
  • Sponsors Pfizer

Most Recent Events

  • 27 Nov 2023 Status changed from active, no longer recruiting to completed.
  • 24 Oct 2023 Results of analysis of final overall survival (OS) of MONALEESA-2 (ML-2) and PALOMA assessing cost-effectiveness of ribociclib vs palbociclib presented at the 48th European Society for Medical Oncology Congress
  • 06 Jun 2023 Results of Indirect treatment comparison of first-line CDK4/6-inhibitors in post-menopausal patients with HR+/HER2- metastatic breast cancer, from PALOMA-2, MONALEESA-2 and MONARCH-3; presented at the 59th Annual Meeting of the American Society of Clinical Oncology

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