Clinical trial for Anatomic Stage I Breast Cancer AJCC v8
Official title Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer
ClinicalTrials.gov ID: NCT05464810
What this study is testing
What is Letrozole?
Letrozole is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for anatomic stage i breast cancer ajcc v8.
Also referred to as CGS 20267, Femara.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
You likely can't join if
- Patients who are receiving any other investigational agents or an investigational device within 3 months before administration of first dose of study...
- 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...
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina...
- Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to...
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous...
See the full eligibility 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...
- 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 =\ = 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
- 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]...
- 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...
- Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to start of study therapy; angina requiring therapy; symptomatic...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.