Clin2
NCT07227233Possibly a fitRecruiting

AI-guided retrial of CDK4/6 inhibitors for advanced breast cancer

Breast Cancer

Treatments studied

Part of Cancer, Skin clinical trials.

This trial tests whether an artificial intelligence (AI) tool can help doctors decide if it is safe and effective to give you a second course of a CDK4/6 inhibitor drug (like palbociclib, ribociclib, or abemaciclib) plus hormone therapy for advanced (unresectable or metastatic) HR+/HER2- breast cancer. The goal is to only treat people whose cancer is likely to respond based on a special AI analysis of their tumor tissue.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2
Enrollment
105 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You are 18 years or older.
  • You have advanced breast cancer that is hormone receptor positive (HR+) and HER2 negative (HER2-).
  • Your cancer has gotten worse after at least 6 months of a CDK4/6 inhibitor (with or without hormone therapy) for advanced disease, or within 6 months of finishing such treatment after surgery.
  • You have had 0 or 1 prior lines of chemotherapy or antibody-drug conjugates for advanced disease.
  • You must have a recent (within the past 6 months) tumor tissue sample that can be tested by a next-generation sequencing (NGS) test, or be able to have a new biopsy for that test.
  • Your cancer must appear to be sensitive to the CDK4/6 inhibitor drug palbociclib based on the trial's AI tool (called the palbo-VNN model).

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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