A Phase II Study Comparing The Efficacy Of Venetoclax + Fulvestrant Vs. Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy

Official Title

A Phase II, Multicentre, Randomized Study To Compare The Efficacy Of Venetoclax Plus Fulvestrant Versus Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy

Summary:

This is a Phase II, multicentre, open-label, randomized study to compare the efficacy of venetoclax in combination with fulvestrant compared with fulvestrant alone in women with ER+, HER2-negative, inoperable, locally advanced or MBC who experienced disease recurrence or progression during or after treatment with CDK4/6i therapy for at least 8 weeks.

Trial Description

Primary Outcome:

  • Clinical benefit defined as Complete Response (CR), Partial Response (PR) or Sudden Death (SD) lasting >= 24 weeks
Secondary Outcome:
  • Progression Free Survival (PFS)
  • Objective Response (OR)
  • Duration of Response (DOR)
  • Overall Survival (OS)
  • Percentage of participants with adverse events
  • Plasma concentration of Venetoxclax and fulvestrant
  • Mean changes from baseline scores in functional disease/treatment-related symptoms and global health status health-related quality of life (GHS/HRQoL) by cycle
  • Change in baseline pain score as assessed by the pain scale of EORTC QLQ-C30
  • Baseline BCL-2 protein levels as measured by International Council for Harmonisation (IHC) correlating with clinical response measures

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society