Clin2
NCT07366112Possibly a fitRecruiting

CDK4/6 inhibitor plus hormone therapy before breast cancer surgery

Hormone Receptor-Positive Breast CancerHigh-risk Breast CancerEarly-Stage Breast CancerHER2-negative Breast CancerctDNA Monitoring

Part of Cancer, Skin clinical trials.

This trial tests a combination of a CDK4/6 inhibitor (a type of targeted therapy) with hormone therapy given before surgery for early-stage breast cancer that is hormone receptor-positive and HER2-negative. It aims to see if this approach can shrink tumors and improve outcomes.

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

Phase
Phase 2
Enrollment
158 people
Ages
18 years to 75 years
Study type
Interventional

Who can take part

  • You are a woman aged 18 to 75, with breast cancer that is hormone receptor-positive (HR+) and HER2-negative.
  • Your tumor must be measurable on scans and be at a certain stage (like T1c, T2, or T3, with or without lymph node involvement, but not spread to distant organs).
  • You must be in good general health (ECOG score 0-1) and have adequate blood counts, kidney, liver, and heart function.
  • You cannot have had any prior treatment for this breast cancer (like surgery, chemotherapy, or radiation).
  • You must not have other serious health problems like recent heart issues, active infections, or other cancers (except certain cured ones).
  • You agree to extra blood tests for ctDNA during the study and to use non-hormonal birth control if you could become pregnant.

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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