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

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

Completed
Phase of Trial: Phase I/II

Latest Information Update: 05 Jun 2018

At a glance

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

    • 05 Jun 2018 Results (n=311) assessing the frequency of hematologic adverse events 30 d before and after dose reduction (during each treatment C1-C6) among patients who required palbociclib dose reduction using pooled data from 3 randomized phase 2 and 3 studies (PALOMA-1, PALOMA-2 and PALOMA-3), presented at the 54th Annual Meeting of the American Society of Clinical Oncology.
    • 16 Jan 2018 Status changed from active, no longer recruiting to completed.
    • 12 Jan 2018 This study has been completed in Hungary (End date: 2017-12-20) as per European Clinical Trials Database.
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