Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer

This early phase I trial tests whether letrozole with simvastatin works better than letrozole alone to stop tumor cell proliferation in patients with stage I-III hormone receptor positive, HER2 negative invasive breast cancer. Letrozole and simvastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. The addition of simvastatin to letrozole may be more effective at stopping the growth of cancer cells than letrozole alone.

Trial Details

NCT ID
NCT05464810
Phase
EARLY_PHASE1
Sponsor
Emory University
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • Letrozole
  • Simvastatin
Locations (sample)
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Atlanta, Georgia, United States|33.749,-84.38798

Key Eligibility Criteria

  • Age \>= 18 years
  • Biopsy proven hormone receptor positive, HER2 negative stage I-III invasive breast cancer
  • Estrogen receptor (ER) and/or progesterone receptor (PR) positivity are defined as \>= 10% of cells expressing hormonal receptors via IHC analysis
  • HER2 negativity is defined as either of the following by local laboratory assessment

For full eligibility, visit ClinicalTrials.gov.

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