Artificial Intelligence and Machine Learning to Guide CDK4/6 Inhibitor Rechallenge in Breast Cancer.
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek powyżej 18 lat
- •Ogólny stan zdrowia pozwalający na uczestnictwo w badaniu (skala 0-2)
- •Zdolność do zrozumienia i podpisania dokumentu zgody
- •Zaawansowany rak piersi (nie do operacji lub z przerzutami) potwierdzony badaniem histologicznym, dodatni na receptory hormonalne, ujemny na receptor HER2
- •Choroba wrażliwa na terapię hormonalną (brak wznowy w pierwszych 2 latach leczenia lub progresja w pierwszych 6 miesiącach pierwszej linii terapii)
- •Progresja choroby po minimum 6 miesiącach leczenia inhibitorem CDK4/6 lub w ciągu 6 miesięcy od zakończenia takiej terapii
- •Możliwość przeprowadzenia sekwencjonowania DNA nowotworu (lub dostęp do wyników z ostatnich 6 miesięcy)
- •Prawidłowe wyniki badań krwi (leukocyty, hemoglobina, neutrofile, płytki)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- April 9, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
University of California, San Diego
La Jolla, United States
Trial contact
Kay Yeung, MD, PhD
Breast Research Team
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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