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

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT07227233
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • A CDK4/6 inhibitor different from the first that the participant had received, plus fulvestrant. — DRUG
    A CDK4/6 inhibitor different from the first that the participant had received, plus fulvestrant.
  • Treatment of physician's choice — DRUG
    Treatment of physician's choice, excluding CDK4/6 inhibitors.

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
105 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Second CDK4/6 inhibitor plus fulvestrant
    A CDK4/6 inhibitor different from the first that the participant had received, plus fulvestrant.
  • Active Comparator: Treatment of physician's choice
    Treatment of physician's choice, excluding CDK4/6 inhibitors.

Primary Outcome Measure

Progression free survival [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San DiegoLa JollaCalifornia92093
Kay Yeung, MD, PhD
[email protected]
858-822-5354
Breast Research Team
[email protected]
858-822-5354

Find similar trials in La Jolla, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of California, San Diego· La Jolla, CA

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