AI-Guided CDK4/6 Inhibitor Retreatment for Breast Cancer

This study is for people with advanced breast cancer that is hormone receptor positive (HR+) and HER2-negative (HER2-). You would have already received one CDK4/6 inhibitor (a type of targeted therapy) and your cancer has progressed. The goal is to see if an artificial intelligence (AI) model can help doctors choose the best second CDK4/6 inhibitor for you, combined with fulvestrant (Faslodex). Some participants will receive a different CDK4/6 inhibitor plus fulvestrant, while others will receive treatment chosen by their doctor (excluding CDK4/6 inhibitors). The main question is whether the AI-guided treatment can keep the cancer from getting worse for a longer time, measured at 6 months.

Study design
This is an open-label, randomized study involving about 105 participants. It compares two treatment approaches to see which is more effective.
What's involved
You will need to provide a tumor biopsy for genetic testing. You must also be willing to follow all study procedures and be available for the study's duration.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome of how long it takes for the cancer to get worse will be measured at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07227233

Artificial Intelligence and Machine Learning to Guide CDK4/6 Inhibitor Rechallenge in Breast Cancer.

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of California, San Diego
~105 participants
Updated 2026-04-09 on ClinicalTrials.gov
What's tested:A CDK4/6 inhibitor different from the first that the participant had received, plus fulvestrant.Treatment of physician's choice

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival
Measured over 6 months
Breast Cancer
1 sites across 1 states
California1
  • Kay Yeung, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Diego

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  • Progression free survival6 months

    Rate of progression free survival at 6 months after randomization.