Clinical Trials

Scientists in the CAPMM have invented technology to make basic discoveries about disease mechanisms, to profile molecules relevant to individualized patient therapy, discover new chemoprevention strategies, and test these discoveries and hypothesis in clinical trials. The Center for Applied Proteomics and Molecular Medicine is working in collaboration with Inova Fairfax Hospital and the Side-Out Foundation to conduct clinical trials for breast cancer prevention and personalized breast cancer treatment. More clinical trials are being planned for other cancers.

The team also developed a nanoparticle technology, licensed to Ceres Nanosciences, which is being evaluated in a clinical trial at Inova Fairfax Hospital for early detection of Lyme disease.

Study of the Efficacy of Chloroquine in the Treatment of Ductal Carcinoma in Situ (The PINC Trial)

The overall goal of this trial is to test a new therapy that has the potential to kill pre invasive early stage breast cancer before it can become invasive and life threatening. Our research (Espina et al) has identified a new therapeutic target, autophagy, that is used by the pre invasive cancer cells to survive inside the breast milk ducts. The autophagy pathway is inhibited by the oral medication chloroquine. The PINC trial will test the hypothesis that chloroquine will suppress or kill breast ductal carcinoma in situ (DCIS) cells, which are the precursor to invasive ductal breast carcinoma. Participants will receive either chloroquine standard dose (500mg/week) or chloroquine low dose (250mg/week) for 1 month prior to surgical removal of the DCIS.

If you are a breast cancer patient and have a diagnosis of low, intermediate or high grade ductal carcinoma in situ or ductal carcinoma in situ with microinvasion you may be eligible to participate in the PINC trial.  For additional eligibility criteria, visit the clinical website and contact Heather Huryk (703-776-4021) for further details.

Virginia Cancer Specialists, PC, Fairfax, Virginia
Medical Oncology and Hematology Associates of Northern Virginia, Fairfax,Virginia
Virginia Surgery Associates, Fairfax, Virginia
Inova Fairfax Hospital, Fairfax Virginia

Contact: Heather Huryk, Phone: 703-776-4021, Email:

Sponsors and Collaborators:
Inova Health Care Services
George Mason University
Department of Defense
U.S. Army Medical Research Materiel Command

Clinical Trials.Gov Identifier: NCT01023477

Pilot Study Using Molecular Profiling to Find Potential Targets and Select Treatments for Patients With Metastatic Breast Cancer (Side-Out)

The purpose of this study is to combine the data derived from our unique reverse phase array technology along with genomic analysis of metastatic breast tumor samples to provide physicians with key missing molecular information about the metastatic tumor from each of their patients.  This information is used by the treating physicians to decide what therapies would be best for their patients. The outcome will be determined by the response rate (percent of patients that do not have disease progression) after a 4 month course of physician directed therapy.

If you are a patient with metastatic breast cancer and your disease has progressed after being treated with at least 3 prior chemotherapeutic or biological regimens, you may be eligible to participate in the Side-Out trial.  For additional eligibility criteria visit the clinical website and contact the clinical trial coordinators listed below for further details.

TGen Clinical Research Services Recruiting, Scottsdale, Arizona
Contact: Joyce Schaffer, RN, MSN, OCN  480-323-1339     
Contact: Gayle Jameson, MSN, ACNP-BC, AOCN  480-323-1350     
Fairfax North Virginia Hematology Oncology, Fairfax, Virginia
Contact:  Stacey Banks, Phone: 703-208-3148 Email:
Contact: Chloe Hamilton Email:

Sponsors and Collaborators:
TGen Drug Development Services
Side-Out Foundation

Clinical Trials.Gov Identifier: NCT01074814

I SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

The purposes of this study are: 1) to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors, 2) identify tissue and blood biomarkers that correlate and predict response to each therapy and 3) learn more about which early indicators of response are predictors of treatment success.

Locations:                                                                                                                                                                        Inova Health System, Fairfax, Virginia
Contact:  Alyssa Bruflodt, Phone: 703-776-3565, Email:
Georgetown University Medical Center, District of Columbia
Contact: Minetta Liu, MD, 202-444-3677,
Additional nationwide locations listed at

Sponsors and Collaborators:
Foundation for the National Institutes of Health
Side-Out Foundation

Clinical Trials.Gov Identifier:  NCT01042379 identifier accessed from, provided by the U.S. National Library of Medicine, as of October 12, 2011