Study on Using Artificial Intelligence to Guide CDK4/6 Inhibitor Treatment in Advanced Breast Cancer

Sponsor: University of California, San Diego

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07227233

Provider View

This clinical trial is exploring whether an artificial intelligence model can help identify patients with advanced breast cancer who might benefit from a second round of CDK4/6 inhibitor treatment after the first one has stopped working. The study focuses on patients with hormone receptor positive, HER2-negative advanced breast cancer.

Patient Parameters

Program Overview

The aim of this study is to see if an artificial intelligence model can predict which patients with advanced breast cancer will respond to a second CDK4/6 inhibitor treatment after the first one has stopped working. The study will compare the effectiveness of this AI-guided treatment, combined with the drug fulvestrant, against other treatments chosen by doctors. Participants will take their assigned treatment, visit the clinic monthly for checkups and tests, and keep a diary of their medication.

Description

This study is testing an artificial intelligence model called palbo-VNN to help choose treatments for patients with advanced breast cancer that is hormone receptor positive and HER2-negative. These patients have already been treated with a CDK4/6 inhibitor but need further treatment. The study will see if the AI model can predict who will benefit from a second CDK4/6 inhibitor combined with fulvestrant, compared to other treatments chosen by doctors.

Participants will have their tumors analyzed using next-generation sequencing to see if they are likely to respond to a second CDK4/6 inhibitor. Those predicted to respond will be randomly assigned to receive either the second CDK4/6 inhibitor with fulvestrant or a different treatment chosen by their doctor. The study will measure how long it takes for the cancer to worsen, the overall response rate, and the quality of life of participants. Safety of the treatments will also be evaluated.

Participants will need to visit the clinic monthly for checkups and tests, and they will keep a diary of their medication. The study will also look at how changes in the tumor's genetic makeup affect treatment outcomes, which could improve the AI model's predictions in the future.

Eligibility Criteria

Inclusion Criteria

  • Age over 18 years
  • Good overall health with a performance status score of 0 to 2
  • Ability to understand and sign a consent form
  • Willingness to follow study procedures and be available for the study duration
  • Have advanced breast cancer that is hormone receptor positive and HER2-negative
  • Cancer must have progressed after at least 6 months of previous CDK4/6 inhibitor treatment
  • Eligible for another round of CDK4/6 inhibitor treatment
  • Have had no more than one prior line of chemotherapy in the metastatic setting
  • Have recent next-generation sequencing results from a tumor biopsy
  • Predicted to respond to palbociclib by the AI model
  • Have adequate organ and bone marrow function
  • Use effective contraception if of reproductive potential
  • Palliative radiotherapy is allowed
  • Stable brain metastases are allowed if no immediate treatment is needed
  • HIV-positive patients on effective therapy are eligible
  • Hepatitis B and C patients with controlled or cured infections are eligible
  • Other cancers that do not interfere with the study are allowed

Exclusion Criteria

  • Life expectancy less than 6 months
  • Medical or psychiatric conditions that prevent safe treatment or study participation
  • Recent use of other investigational drugs with known interactions
  • Uncontrolled illnesses like active infections, heart failure, or severe lung disease
  • Inability to access standard treatments like abemaciclib, palbociclib, ribociclib, or fulvestrant
  • Pregnancy or breastfeeding

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