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Evaluation of the Accuracy of Percutaneous Biopsy by Vacuum-assisted Biopsy (VAB) to Assess Pathological Complete Response in Patients With Clinical and Radiological Complete Response After Neoadjuvant Chemotherapy (NeoVAB)

Study acronym: NeoVAB
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 17, 2025 (before its estimated February 28, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Trial status: Recruiting to Active, Not Recruiting Site details revisedv7 Show 1 more changeShow less
    • Site details revised
  2. Notable Primary completion date: Feb 9, 2024 to Feb 28, 2025 Completion date: Apr 9, 2024 to Apr 8, 2025v6 Show 1 more changeShow less
    • Completion date: Apr 9, 2024 to Apr 8, 2025
  3. Notable Primary completion date: Aug 30, 2019 to Feb 9, 2024 Start date: Jun 7, 2019 to Aug 30, 2019 · Completion date: Aug 30, 2021 to Apr 9, 2024v5 Show 2 more changesShow less
    • Start date: Jun 7, 2019 to Aug 30, 2019
    • Completion date: Aug 30, 2021 to Apr 9, 2024
  4. Notable Trial status: Not Yet Recruiting to Recruiting Primary completion date changed from estimate of Nov 2021 to Aug 30, 2019 · Completion date: Nov 2021 to Aug 30, 2021 · Start date changed from estimate of May 2019 to Jun 7, 2019 · 1 morev4 Show 4 more changesShow less
    • Primary completion date changed from estimate of Nov 2021 to Aug 30, 2019
    • Completion date: Nov 2021 to Aug 30, 2021
    • Start date changed from estimate of May 2019 to Jun 7, 2019
    • Site details revised
  5. Minor Enrollment target: 66 to 67v3
  6. Minor Study title shortened, about 4 wordsv2 See this version in full on ClinicalTrials.gov ↗
  7. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Breast cancer is the most commonly diagnosed cancer and the leading cause of cancer death in females in the world. Neoadjuvant chemotherapy (NAC) is increasingly used in patients with operable breast cancer to enhance the likelihood of breast conservation. New generation of treatments or combinations lead to a high rate of pathological complete responses (pCR) in patients with human epidermal growth factor receptor 2 positive (HER2) and triple negative tumours. Safe omission of surgery in patients who receive NAC and achieve radiologic complete response depends on the ability to accurately estimate pCR preoperatively. If pathological complete response after NAC could be accurately assessed by VAB, surgery could be avoided. In the context of new treatments or combinations with an increased pCR rate, this new strategy could induce major changes in clinical practice, leading to breast surgery de-escalation.
Trial Details
NCT Number NCT03876951
Lead Sponsor Centre Georges Francois Leclerc
Conditions Vacuum-assisted Biopsy
Enrollment 67 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov