At Shenandoah Oncology, research is an integral part of our comprehensive efforts to provide cancer patients in our community with access to the latest and most advanced therapies and treatment options. As a member of US Oncology Research and as a clinical research affiliate of VCU Massey Cancer Center, we are pleased to share this list of clinical trials currently enrolling at our practice.
BREAST CANCER – ADJUVANT
NSABP B-53 / S1207
Phase 3 study comparing standard adjuvant endocrine therapy to the combination of standard endocrine therapy plus everolimus in patients with high-risk hormone receptor positive and HER2 negative breast cancer. Studies show that the addition of everolimus to standard endocrine therapy can delay disease progression in metastatic disease, and the goal of this study is to establish if the combination of everolimus and standard endocrine therapy will increase the cure rate in the adjuvant setting.
Phase 3 study of adjuvant therapy comparing doxorubicin and cyclophosphamide followed by weekly paclitaxel with or without carboplatin for node-positive or high-risk node-negative triple negative invasive breast cancer.
BREAST CANCER – RECURRENT/ADVANCED
Phase 3 study comparing standard chemotherapy agent paclitaxel to the combination of standard chemotherapy agent paclitaxel plus the investigational Aurora A kinase inhibitor alisertib in patients with recurrent or advanced breast cancer. Aurora A kinase plays an important role in mitosis, and inhibition of this protein has been shown to slow cell proliferation and may overcome resistance to paclitaxel.
Phase 3 study of standard endocrine therapy plus entinostat or placebo in patients with advanced hormone receptor positive breast cancer. Etinostat is an investigationl HDAC inhibitor that regulates gene expression with the goal of overcoming resistance to endocrine therapy. Etinostat was granted Breakthrough Therapy designation by the FDA in 2013.
Phase 2 double-blind, placebo-controlled study of atorvastatin v. placebo to determine if atorvastatin protects against cardiotoxicity after initiation of anthracycline-based chemotherapy for breast cancer or lymphoma. Cardiac MRI will be used to measure left ventricular ejection fraction.
CHRONIC LYMPHOCYTIC LYMPHOMA
InformCLL: A disease registry for patients with chronic lymphocytic leukemia. The study will track current treatment patterns among CLL patients and explore the associations with baseline patient characteristics, healthcare resource utilization, and clinical outcomes.
LUNG CANCER, NON SMALL CELL
Master Protocol of Phase 2 studies of nivolumab in advanced NSCLC using nivolumab as maintenance after induction chemotherapy or as first-line treatment alone or in combination with standard of care therapies. Nivolumab is a fully human monoclonal antibody that is designed to cancel inhibitory signals and augment the body's immune response.
NONE AT PRESENT
NONE AT PRESENT
Phase 3 study of androgen deprivation therapy and bicalutamide v. androgen deprivation therapy and TAK-700 for newly diagnosed metastatic hormone sensitive prostate cancer. TAK-700 inhibits the production of androgens that could cause tumor growth.
NONE AT PRESENT
Randomized phase 3 study evaluating the role of weight loss in adjuvant treatment of overweight or obese women with early HER-2 negative breast cancer.