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

Study acronym: PALVEN
StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Jun 2024 to Jun 2025v11
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 36 to confirmed 17
    • Site details revised at 3 of 3 sites
    v10
  3. Primary completion date: Mar 2023 to Jun 2024
    • Study completion date: Dec 2024 to Dec 2025
    v9
  4. Re-verified, no change to tracked fieldsv8
  5. Primary completion date: Nov 2022 to Mar 2023
    • Study completion date: Mar 2023 to Dec 2024
    • Site details revised at 1 of 3 sites
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2019 to Sep 25, 2019
    • Site details revised at 3 of 3 sites
    v6
  2. Start date: Aug 2019 to Sep 2019
    • Site contacts updated at 1 of 3 sites
    v5
  3. Study sites: 0 to 3v4
  4. Start date: May 2019 to Aug 2019v3
  5. Secondary endpoints: details revised at 1 of 5 entries
    • Study title shortened, about 8 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03900884
Lead Sponsor Peter MacCallum Cancer Centre, Australia
Conditions
(from sponsor)		 Breast Neoplasm Female
Enrollment 17 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov