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Back|NCT05464810Recruiting
Official Title

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

Phase
Early Phase 1
Sponsor
Emory University
Enrollment
40
Timeline
Sep 2022 → Apr 2027
About This Study

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.

Eligibility Criteria

Inclusion Criteria

  • 1Age \>= 18 years
  • 2Biopsy proven hormone receptor positive, HER2 negative stage I-III invasive breast cancer
  • 3Estrogen receptor (ER) and/or progesterone receptor (PR) positivity are defined as \>= 10% of cells expressing hormonal receptors via IHC analysis
  • 4HER2 negativity is defined as either of the following by local laboratory assessment
  • 5IHC 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)
  • 6Minimum primary tumor size 5 mm on any breast imaging (mammogram, ultrasound, magnetic resonance imaging \[MRI\])
  • 7Baseline Ki-67 IHC expression on tumor tissue \>= 10%
  • 8Post-menopausal women
  • 9Prior bilateral oophorectomy
  • 10Age \>= 55 years
  • 11Age \< 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
  • 12Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • 13Prior treatment:
  • 14No systemic therapy (chemotherapy, immunotherapy, endocrine therapy, and/or investigational therapy) within 3 months of trial enrollment
  • 15No statins, fibrates, or ezetimibe within 3 months of trial enrollment
  • 16No active liver disease
  • 17Hemoglobin \>= 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)
  • 18Absolute 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)
  • 19Platelets \>= 100,000/mcL (within 14 days prior to initiation of study treatment)
  • 20Total bilirubin =\< 2 institutional upper limit of normal (ULN) (within 14 days prior to initiation of study treatment)
  • 21Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 institutional ULN (within 14 days prior to initiation of study treatment)
  • 22Serum creatinine =\< 2 mg/dL (or glomerular filtration rate \>= 40 mL/min) (within 14 days prior to initiation of study treatment)
  • 23Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions
  • 24Be willing and able to provide written informed consent for the trial

Exclusion Criteria

  • 1Patients who are receiving any other investigational agents or an investigational device within 3 months before administration of first dose of study drugs
  • 2History of allergic reactions attributed to compounds of similar chemical or biologic composition to simvastatin and/or letrozole
  • 3Concomitant 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
  • 4Uncontrolled 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
  • 5Significant 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
  • 6Has 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

Locations

4 sites participating in this study

Emory University Hospital Midtown

Atlanta, Georgia 30308

Recruiting

Ruth L. Sacks, MD

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

Ruth L. Sacks, MD

Emory Saint Joseph's Hospital

Atlanta, Georgia 30342

Recruiting

Ruth L. Sacks, MD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →