Is NCT05464810 recruiting in Atlanta, GA?

Yes, NCT05464810 is currently recruiting participants at its Atlanta, GA location. This anatomic stage i breast cancer ajcc v8 clinical trial is actively enrolling qualified participants.

Is participation in this Atlanta clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Anatomic Stage I Breast Cancer AJCC v8 Clinical Trial in Atlanta, GA

Q: How do I join the anatomic stage i breast cancer ajcc v8 clinical trial in Atlanta?

To join this clinical trial in Atlanta, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Anatomic Stage I Breast Cancer AJCC v8 Study in Atlanta

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.

Sponsor: Emory University

Who Can Participate

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 (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 Criteria

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Atlanta?

Yes, this clinical trial (NCT05464810) has an active research site in Atlanta, GA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Anatomic Stage I Breast Cancer AJCC v8 Treatment Options in Atlanta, GA

If you're searching for anatomic stage i breast cancer ajcc v8 treatment options in Atlanta, GA, this clinical trial (NCT05464810) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Atlanta research site is actively enrolling participants for this clinical trial. You'll receive care from experienced anatomic stage i breast cancer ajcc v8 specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all anatomic stage i breast cancer ajcc v8 clinical trials near you to find additional studies recruiting in your area.

Anatomic Stage I Breast Cancer AJCC v8 Clinical Trial in Atlanta, GA

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