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An International, Non-controlled Phase II Trial to Identify the Molecular Mechanisms of Resistance and Sensitivity to Palbociclib Re-challenge Upon Progression to a Palbociclib Combination in ER-positive Metastatic Breast Cancer Patients

Trial Profile

An International, Non-controlled Phase II Trial to Identify the Molecular Mechanisms of Resistance and Sensitivity to Palbociclib Re-challenge Upon Progression to a Palbociclib Combination in ER-positive Metastatic Breast Cancer Patients

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 30 Sep 2022

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At a glance

  • Drugs Palbociclib (Primary) ; Anastrozole; Exemestane; Fulvestrant; Letrozole; Tamoxifen
  • Indications Advanced breast cancer
  • Focus Pharmacodynamics; Pharmacogenomic; Proof of concept; Therapeutic Use
  • Acronyms BioPER
  • Sponsors Medica Scientia Innovation Research
  • Most Recent Events

    • 27 Sep 2022 Primary endpoint (From a clinical point of view, the primary endpoint for this study is the percentage of patients that achieve clinical benefit (CBR) defined as complete response, partial response, or stable disease for at least 24 weeks per RECIST v.1.1.) has been met, according to Results published in the Clinical Cancer Research.
    • 27 Sep 2022 Primary endpoint (Biological endpoint) has been met, according to Results published in the Clinical Cancer Research.
    • 27 Sep 2022 Results assessing efficacy and exploratory biomarkers of continuing palbociclib plus endocrine therapy (ET) beyond progression on prior palbociclib-based regimen in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer , published in the Clinical Cancer Research.
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