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.
Phase 3, open-label study of Abemaciclib combined with standard adjuvant endocrine therapy versus standard endocrine therapy alone in patients with high risk, node positive, early stage, hormone receptor positive, HER-2 negative patients. Abemaciclib is a CDK4 and CDK6 inhibitor that was approved by the FDA in September 2017 for use in certain breast cancers.
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 2 open label study to evaluate the efficacy and safety of Eribulin Mesylate in combination with Pembrolizumab in subjects with metastatic triple negative breast cancer with 1-2 previous lines of chemotherapy in the metastatic setting
Phase 3 study of standard endocrine therapy plus entinostat or placebo in patients with advanced hormone receptor positive breast cancer. Entinostat is an investigational HDAC inhibitor that regulates gene expression with the goal of overcoming resistance to endocrine therapy. Entinostat 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
Phase 2 study of HDAC inhibitor, Mocetinostat, in combination with PD-L1 inhibitor, Durvalumab, in advanced or metastatic non-small cell lung cancer.
Phase 2 double-blind trial comparing Polatuzamab vedotin with Rituximab and CHP versus Rituximab and CHOP in previously untreated patients with diffuse large B-cell Lymphoma.
NONE AT PRESENT
Phase 3 randomized study of Atezolizumab versus placebo administered in combination with Paclitaxel, Carboplatin, and Bevacizumab to patients with newly diagnosed Stage III or IV ovarian, fallopian tube, or primary peritoneal cancer.
NONE AT PRESENT
Phase 3 open-label study to study the efficacy and safety of Pembrolizumab plus Epacadostat versus standard of care (Sunitinib or Pazopanib) as first-line treatment for locally advanced or metastatic renal cell carcinoma. Epacadostat is an IDO1 inhibitor.
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.