Early Phase 1 Breast Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are 18 years of age or older
• You have been diagnosed with breast cancer confirmed by biopsy, where the cancer is hormone receptor positive, HER2 negative, and at an early to locally advanced stage (Stage I–III)
• Your tumor is at least 5 mm in size as seen on a mammogram, ultrasound, or MRI
• Your tumor shows a certain level of a growth marker called Ki-67 (at least 10%) on lab testing (confirm with trial site)
• You are post-menopausal — meaning you have had both ovaries removed, are 55 or older, or have not had a period for 12 or more months under specific conditions (confirm with trial site)
• You are generally able to carry out daily activities (your overall health and functioning meets a standard scale rating of 0–2) (confirm with trial site)
• You have not received chemotherapy, immunotherapy, hormone therapy, or other experimental treatments in the past 3 months
• You have not taken cholesterol-lowering medications (statins, fibrates, or ezetimibe) in the past 3 months
• You do not have active liver disease
• Your recent blood test results (within the last 14 days) show your blood counts, liver function, and kidney function are within acceptable ranges
• You are willing and able to attend scheduled visits, take medications as directed, and follow all study requirements
• You are willing to sign a written consent form to participate

Who may not be able to join:

• You have taken part in another clinical trial or used an experimental treatment or device within the past 3 months
• You have had a serious allergic reaction to medications similar to simvastatin (a cholesterol drug) or letrozole (a hormone therapy)
• You are currently taking certain medications that can interfere with how the study drugs work, including some antibiotics, antifungals, HIV medications, or other specific drugs (confirm with trial site for the full list)
• You have an uncontrolled ongoing illness, such as an active infection, serious heart problems, substance use disorder, or a mental health condition that could make it hard to follow the study plan
• You have had a serious heart or blood vessel event (such as a heart attack or stroke) within the past 3 months, or you currently have severe or poorly controlled heart disease or very high blood pressure
• You have another cancer that is currently growing or requires active treatment (skin cancers that have been successfully treated may be an exception — confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.