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Phase 1/2, Open-label, Randomized Study Of The Safety, Efficacy, And Pharmacokinetics Of Letrozole Plus Pd 0332991 (Oral Cdk 4/6 Inhibitor) And Letrozole Single Agent For The First-line Treatment Of Er Positive, Her2 Negative Advanced Breast Cancer In Postmenopausal Women

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Trial Profile

Phase 1/2, Open-label, Randomized Study Of The Safety, Efficacy, And Pharmacokinetics Of Letrozole Plus Pd 0332991 (Oral Cdk 4/6 Inhibitor) And Letrozole Single Agent For The First-line Treatment Of Er Positive, Her2 Negative Advanced Breast Cancer In Postmenopausal Women

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 15 Feb 2022

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At a glance

  • Drugs Letrozole (Primary) ; Palbociclib (Primary)
  • Indications Adenocarcinoma; Advanced breast cancer; HER2 negative breast cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms PALOMA-1
  • Sponsors Pfizer

    • Most Recent Events

    • 03 Dec 2021 Data was used from trials ( MONALEESA-2, PALOMA 1 and 2) to develop the cost-effectiveness model for ribociclib (Kisqali + letrozole versus palbociclib + letrozole in the treatment of HR-positive, HER2-negative advanced breast cancer patients presented at the 24th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research
    • 19 Nov 2020 Results assessing effectiveness of palbociclib plus letrozole or fulvestrant in HR+/HER2- post-menopausal advanced or metastatic breast cancer patients using data from PALOMA-1, PALOMA-2 & PALOMA-3 studies in Portugal, presented at the 23rd Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research.
    • 21 Sep 2020 Results (N= 507) of pooled analysis assessing the Comparative effectiveness of ribociclib plus fulvestrant (RIB+FUL) versus palbociclib plus letrozole by matching-adjusted indirect comparison (MAIC), presented at the 45th European Society for Medical Oncology Congress
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