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

• 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