Artificial Intelligence and Machine Learning-Enhanced Biomarker-dRiven CDK4/6 Inhibitor Rechallenge in HR+ HER2- Advanced Breast Tumors.
University of California, San Diego
Summary
The goal of this clinical trial is to learn if an artificial intelligence model will be able to select patients with advanced breast cancer who may respond to a second cyclin-dependent kinase 4/6 (CDK4/6) inhibitor after they have progressed on the first CDK4/6 inhibitor. Patients for this study need to have hormone receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer. The main questions the study aims to answer are: If the artificial intelligence model says that a patient's tumor should respond to the second CDK4/6 inhibitor, and that patient receives the second CDK4/6 inhibitor together with fulvestrant (an endocrine therapy also called Faslodex), will it take longer for the tumor to get worse than if the patient receives another type of therapy? Will the tumor respond better? Will the therapy be safe? Researchers will compare the combination of a second CDK4/6 inhibitor plus fulvestrant to the therapy chosen by the physician. Participants will: Take the assigned therapy based on the way the therapy is usually prescribed. Visit the clinic once every month for checkups, tests, and questionnaires. Keep a diary of the pills they take at home.
Description
This is a phase II, open-label, randomized controlled single-site study to assess the clinical utility of an artificial intelligence model, called palbo-VNN, to guide treatment selection in patients with hormone receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) advanced (unresectable or metastatic) breast cancer who have progressed after prior treatment with a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. The investigators hypothesize that: (1) the model will be able to predict who will respond to a second CDK4/6 inhibitors combined with fulvestrant (Faslodex)…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age \>18 years 2. Eastern Cooperative Oncology Group performance status 0-2 3. Ability to understand and sign the informed consent document 4. Stated willingness to comply with all study procedures and availability for the duration of the study 5. Advanced breast cancer (defined as unresectable or metastatic) histologically confirmed hormone receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer per American Society of Clinical Oncology/College of American Pathologists (CAP) guidelines. 6. Endocrine-sensitive disease per…
Interventions
- DrugA CDK4/6 inhibitor different from the first that the participant had received, plus fulvestrant.
A CDK4/6 inhibitor different from the first that the participant had received, plus fulvestrant.
- DrugTreatment of physician's choice
Treatment of physician's choice, excluding CDK4/6 inhibitors.
Location
- University of California, San DiegoLa Jolla, California