Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-24 @ 6:57 PM
Ignite Modification Date:
2025-12-25 @ 4:30 PM
NCT ID:
NCT03284957
Pre Assignment Details:
The study consisted of dose-escalation phases (Parts A, C, H, J), safety run-in phase (Part F) and dose-expansion phases (Parts B, D, G, I, K). Participants received amcenestrant as monotherapy (Parts A, B) or in combination with palbociclib (Parts C, D), alpelisib (Part F), everolimus (Parts H, I) or abemaciclib (Part J). Parts G and K were never initiated due to the early termination of the study. Reason for not completed = reason for permanent full treatment discontinuation.
Recruitment Details:
This study was conducted at 25 sites in 10 countries between 20-Sep-2017 and 08-Nov-2024. A total of 136 participants were enrolled in the study. Sponsor decided to prematurely stop the study, it was not linked to any safety concern.
Study:
NCT03284957
Study Brief:
Results Section:
NCT03284957