Clinical Trial

Palbociclib, Letrozole & Venetoclax in ER and BCL-2 Positive Breast Cancer

Study acronym: PALVEN
Active, Not Recruiting Phase 1
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Record status
This record was last updated November 7, 2024 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.
Summary
This study is investigating the combination of palbociclib, letrozole and venetoclax in ER and BCL-2 positive locally advanced or metastatic breast cancer. It is hypothesised that venetoclax may augment the actions of palbociclib and letrozole in these patient groups. The primary objective of the study is to determine the maximum tolerated dose of the combination treatment, which can be used in subsequent studies. The study will also investigate disease response and survival. Participants will receive palbociclib (daily, on days 1-21 of each 28 day cycle), letrozole (daily, on days 1-28 of each 28 day cycle) and venetoclax (daily, on days 1-21 of each 28 day cycle) until the last patient has completed 18 months treatment on the study.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2019-04-02; most recent amendment 2024-11-06.
Status change: Recruiting → Active, Not Recruiting 2024-05-22
Status change: Not Yet Recruiting → Recruiting 2020-06-09
Trial Details
NCT Number NCT03900884
Lead Sponsor Peter MacCallum Cancer Centre, Australia
Conditions Breast Neoplasm Female
Enrollment 17 participants
Start Date 2019-09-25
Primary Completion 2025-06 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2024-11-07