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Letrozole with or without Simvastatin for Early-Stage Breast Cancer

This study is testing if adding simvastatin to letrozole works better than letrozole alone for patients with stage I-III hormone receptor-positive, HER2-negative breast cancer. Letrozole and simvastatin are drugs that may help stop cancer cells from growing by blocking certain enzymes. Researchers want to see if combining these drugs is more effective at reducing tumor cell growth before surgery. To join, you must be at least 18 years old, a woman, and have biopsy-proven hormone receptor-positive, HER2-negative invasive breast cancer. The study will measure changes in a marker called Ki-67 (a sign of cell growth) to see how well the treatments work. This is an early-phase study with 40 participants, and its current status is unclear.

Study design
This interventional study plans to enroll 40 women. It compares letrozole with simvastatin to letrozole alone.
What's involved
You will receive either letrozole or letrozole with simvastatin by mouth (PO). Tumor cell growth will be measured from before surgery to 14 days after starting treatment.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes from before surgery to 14 days after preoperative therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05464810

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

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Emory University
~40 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:LetrozoleSimvastatin

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean percentage change in Ki-67
Measured over From pre-surgical baseline to 14 days following preoperative therapy

Conditions

Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
HER2-Negative Breast Carcinoma
Hormone Receptor-Positive Breast Carcinoma
Invasive Breast Carcinoma

Explore related trials

Breast CarcinomaMKI67 Gene

Where it's being run

4 sites across 1 states
Georgia4

Study leadership

  • Ruth L. Sacks, MD · PRINCIPAL_INVESTIGATOR · Emory University Hospital/Winship Cancer Institute

Who to contact

Ruth L. Sacks, MD
[email protected]
404-778-1345
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 (mammogram, ultrasound, magnetic resonance imaging \[MRI\])
Baseline Ki-67 IHC expression on tumor tissue \>= 10%
Post-menopausal women
Prior bilateral oophorectomy
Age \>= 55 years
Age \< 55 and amenorrheic for 12 months or more in the absence of chemotherapy, endocrine therapy, or ovarian suppression and follicle stimulating hormone (FSH), luteinizing hormone (LH), and estradiol in the postmenopausal range
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Prior treatment:
No systemic therapy (chemotherapy, immunotherapy, endocrine therapy, and/or investigational therapy) within 3 months of trial enrollment
No statins, fibrates, or ezetimibe within 3 months of trial enrollment
No active liver disease
Hemoglobin \>= 9.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 9.0 g/dl is acceptable) (within 14 days prior to initiation of study treatment)
Absolute neutrophil count (ANC) \>= 1,500/mcL (after at least 7 days without growth factor support or transfusion) (within 14 days prior to initiation of study treatment)
Platelets \>= 100,000/mcL (within 14 days prior to initiation of study treatment)
Total bilirubin =\< 2 institutional upper limit of normal (ULN) (within 14 days prior to initiation of study treatment)
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 institutional ULN (within 14 days prior to initiation of study treatment)
Serum creatinine =\< 2 mg/dL (or glomerular filtration rate \>= 40 mL/min) (within 14 days prior to initiation of study treatment)
Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions
Be willing and able to provide written informed consent for the trial

Exclusion

Patients who are receiving any other investigational agents or an investigational device within 3 months before administration of first dose of study drugs
History of allergic reactions attributed to compounds of similar chemical or biologic composition to simvastatin and/or letrozole
Concomitant use of strong CYP3A4 inhibitors (i.e. clarithromycin, erythromycin, itraconazole, ketroconazole, nefazodone, Posaconazole, voriconazole, protease inhibitors \[including boceprevir and telaprevir\], telithromycin, cobicistat-containing products), cyclosporine, danazol, and gemfibrozil
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, substance abuse disorders, or psychiatric illness/social situations that would limit compliance with study requirements
Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to start of study therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association class 3 or 4 congestive heart failure; or uncontrolled grade \>= 3 hypertension (diastolic blood pressure \>= 100 mmHg or systolic blood pressure \>= 160 mmHg) despite antihypertensive therapy
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy

What this trial measures

  • Mean percentage change in Ki-67From pre-surgical baseline to 14 days following preoperative therapy

    Negative change denotes reduction. Ki-67 is a validated surrogate marker for disease-free survival in patients with hormone receptor positive (HR+), HER2- breast cancer. Ki-67 values at 14 days are expressed as geometric mean proportions of the baseline and transformed into percentage change. Geometric mean percentage change of Ki-67 from pre- to post-treatment is calculated and compared between the two treatment arms. A two-sided Mann-Whitney U or Wilcoxon Rank-Sum test is used.