A Phase I Study Comparing Letrozole With and Without Simvastatin Before Surgery in Postmenopausal Women With Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer

What this Trial Is About

Researchers are studying whether combining letrozole with simvastatin works better than letrozole alone to reduce tumor cell growth in postmenopausal women with stage I-III hormone receptor positive, HER2 negative breast cancer. This early phase I trial aims to compare how these treatments affect a biomarker called Ki-67, which indicates tumor proliferation, after 14 days of pre-surgical therapy. The study also evaluates immune responses, pain levels, safety, and other biological markers related to cancer growth and immune activation. Participants are randomly assigned to one of two groups. One group receives letrozole and simvastatin daily for 14 days, while the other group receives letrozole alone daily for the same duration, unless there is disease progression or unacceptable side effects. After the treatment period, participants are followed for 30 days to monitor outcomes and safety. During the study, participants undergo assessments including tissue analysis for tumor and immune markers, blood tests for biomarkers and cholesterol levels, and patient-reported pain questionnaires. Researchers measure changes in Ki-67 from before to after treatment to evaluate tumor response. Safety and tolerability of the treatments are also monitored up to 30 days after surgery. The study helps understand the effects of adding simvastatin to letrozole before surgery in this breast cancer population.

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