A Randomized Window of Opportunity Study of Preoperative Letrozole and Simvastatin Versus Letrozole Alone in Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer
Emory University
Summary
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.
Description
PRIMARY OBJECTIVE: I. To determine if the addition of simvastatin to letrozole compared to letrozole alone will result in a decrease of Ki67, a biomarker of tumor proliferation, in postmenopausal women with stage I-III, hormone receptor positive, HER2 negative breast cancer following 14 days of pre-surgical therapy. SECONDARY OBJECTIVES: I. To determine if the addition of simvastatin to letrozole compared to letrozole alone will result in increased immune activation from pre- to post-treatment, based on the evaluation of the immune subtype composition in the tissue via multiplex immunofluor…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion 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 * IHC 0, 1+, or 2+ and in situ hybridization (ISH) non-amplified (ratio of HER2 to CEP17 \< 2.0 or single probe average HER2 gene copy number \< 4 signals/cell) * Minimum primary tumor size 5 mm on any breast imaging (mamm…
Interventions
- DrugLetrozole
Given PO
- DrugSimvastatin
Given PO
Locations (4)
- Grady Healthcare SystemAtlanta, Georgia
- Emory University Hospital MidtownAtlanta, Georgia
- Emory University Hospital/Winship Cancer InstituteAtlanta, Georgia
- Emory Saint Joseph's HospitalAtlanta, Georgia