Actively Recruiting
Artificial Intelligence and Machine Learning to Guide CDK4/6 Inhibitor Rechallenge in Breast Cancer.
Led by University of California, San Diego · Updated on 2026-04-09
105
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Artificial Intelligence and Machine Learning to Guide CDK4/6 Inhibitor Rechallenge in Breast Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Eastern Cooperative Oncology Group performance status 0-2
- Ability to understand and sign informed consent
- Willingness to comply with study procedures and availability for study duration
- Histologically confirmed advanced hormone receptor positive (HR+) HER2-negative breast cancer
- Endocrine-sensitive disease as defined by ABC7 2023 guidelines
- Disease progression after at least 6 months of prior CDK4/6 inhibitor therapy in metastatic or adjuvant setting
- Eligible and able to receive another line of CDK4/6 inhibitor therapy
- Zero to one prior chemotherapy or antibody-drug conjugate in metastatic setting
- Available or possible next-generation sequencing results from tumor biopsy within 6 months after CDK4/6 inhibitor exposure
- Palbociclib sensitive disease per palbo-VNN model
- Measurable or evaluable disease per RECIST 1.1 criteria
- Adequate organ and marrow function: leukocytes >3000/microliter, hemoglobin >8 g/dl, neutrophils >1200/microliter, platelets >75000/microliter
- For reproductive potential participants: females must use non-hormonal contraception starting 1 month before treatment and during study until 3 months after; males must use condoms or effective contraception during study and 3 months after
- Palliative radiotherapy allowed
- Patients with stable brain metastases or leptomeningeal disease if immediate CNS treatment not needed
- HIV patients on effective therapy with undetectable viral load within 6 months
- Controlled hepatitis B or cured/controlled hepatitis C
- Prior or concurrent malignancy allowed if it does not interfere with study safety or efficacy
You will not qualify if you...
- Life expectancy less than 6 months
- Medical or psychiatric conditions preventing safe use of study treatments or participation
- Receiving investigational agents with known drug interactions within 3 weeks before enrollment
- Uncontrolled illnesses including active infection, heart failure, unstable angina, arrhythmia, lung disease needing oxygen, decompensated cirrhosis, end-stage kidney disease on dialysis, or limiting psychiatric illness
- Lack of access to abemaciclib, palbociclib, ribociclib, or fulvestrant as standard care
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California, San Diego
La Jolla, California, United States, 92093
Actively Recruiting
Research Team
K
Kay Yeung, MD, PhD
CONTACT
B
Breast Research Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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