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Clinical Trials


Breast cancer research studies by attending physicians on staff within Inova Comprehensive Cancer and Research Institute and Inova Women's Services

Last updated August 2013

Read our frequently asked questions about clinical trials  

The list of open research trials below is meant to be a general information resource only and should not replace information given by your physician. Studies may close without warning. For questions regarding the status of an individual study, please contact the person listed with each individual study.

In addition to the consent forms for these studies, additional general disease information and trial search information can be found at the National Cancer Institute site, www.cancer.gov. The U.S. government has a clinical trials site (www.clinicaltrials.gov) with helpful information for patients and trials categorized by specific therapeutic areas.

Translational Research

Protocol/Organization Study Title/Purpose Status
Inova/George Mason University
Transitional Research Institute
Cancer Molecular Profiling Project
Purpose: To study the phosphoproteomic profile of brain, ovarian, colorectal, liver, lung and hematogenous malignancies to classify disease and develop treatments using microarray technology
Principal Investigator: Kirsten Edmiston, MD
Contact Person: Holly Gallimore, 703-776-2688
Open


Site: Breast – Ductal Carcinoma in Situ

Protocol/Organization Study Title/Purpose Status
Inova/George Mason University
Preventing Invasive Breast Neoplasia with Chloroquine (PINC) Trial
Purpose: To study the use of chloroquine in the treatment of ductal carcinoma in situ (DCIS) and in prevention of invasive breast cancer in patients diagnosed with DCIS.
Principal Investigator: Kirsten Edmiston, MD
Contact Person: Holly Gallimore, 703-776-2688
Open


Site: Breast – Neoadjuvant

Protocol/Organization Study Title/Purpose Status
ISPY-2 ISPY-2 Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis
Purpose: To study multiple novel agents in locally advanced breast cancer patients receiving neoadjuvant chemotherapy.
Principal Investigator: Kirsten Edmiston, MD
Contact Person: Holly Gallimore, 703-776-2688; Janine Prime, 703-208-3107; Clara Tran, RN, 703-720-5210
Open


Site: Breast – Adjuvant

Protocol/Organization Study Title/Purpose Status
US Oncology 07-132 A Phase III Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC, for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer
Principal Investigator: Nicholas Robert, MD
Contact Person: Stacey Banks, 703-208-3148
On Hold
RTOG 1005 A Phase III Trial of Accelerated Whole Breast Irradiation with Hypofractionation Plus Concurrent Boost versus Standard Whole Breast Irradiation Plus Sequential Boost For Early-Stage Breast Cancer

This study is open to enrollment at the following sites:

Inova Fairfax Hospital Prinicipal Investigator: Samir Kanani, MD
Contact Person: Christina Krawiecki, CCRC, 703-776-4021

Inova Fairfax Hospital
Prinicipal Investigator: Samir Kanani, MD
Contact Person: Christina Krawiecki, CCRC, 703-776-4021

Inova Alexandria Hospital
Principal Investigator: Jane Grayson, MD
Contact Person: Chloe Hamilton, RN, 703-504-7916 and 703-504-7900
Open


Site: Breast – Locally Recurrent or Metastatic

Protocol/Organization Study Title/Purpose Status
CALGB 40502
A Randomized, Phase III Trial of Weekly Paclitaxel Compared to Weekly Nanoparticle Albumin Bound Nab-Paclitaxel or Ixebepilone Combined with Bevacizumab, as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer
Principal Investigator: Mary Wilkinson, MD
Contact Person: Clara Tran, 703-720-5210
Closed
CALGB 70604  A Randomized, Phase III Study of Standard Dosing versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer
Principal Investigator: Mary Wilkinson, MD
Contact Person: Clara Tran, 703-720-5210
Open
US Oncology 08-223   A Randomized, Phase III, Double-Blind, Placebo-Controlled, Multi-Center Trial of Daily Everolimus in Combination with Trastuzumab and Vinorelbine, in Pretreated Women with HER2/neu Over-Expressing Locally Advanced or Metastatic Breast Cancer
Principal Investigator: Nicholas Robert, MD
Contact Person: Stacey Banks, 703-208-3148
Open
US Oncology 09-097  A Randomized, Phase III, Open-Label Study of Lapatinib plus Trastuzumab versus Trastuzumab as Continued HER2 Suppression Therapy after Completion of First- or Second-line Trastuzumab Plus Chemotherapy, in Subjects with HER2- Positive Metastatic Breast Cancer
Principal Investigator: Nicholas Robert, MD
Contact Person: Stacey Banks, 703-208-3148
Open
US Oncology 09-185 2010EAP: An Open-Label, Expanded Access Protocol of Iniparib in Combination with Gemcitabine/Carboplatin in Patients with ER-, PR-, and HER2-Negative Metastatic Breast Cancer
Principal Investigator: Nicholas Robert, MD
Contact Person: Stacey Banks, 703-208-3148
Open
SIDE-OUT A Pilot Study Utilizing Molecular Profiling by IHC, FISH, DNA Microarray, and Reverse Phase Protein Microarray (RPMA) of Patients' Tumors to Find Potential Targets and Select Treatments, for Patients with Metastatic Breast Cancer
Principal Investigator: Nicholas Robert, MD
Contact Person: Stacey Banks, 703-208-3148 
Open
TRIO 018 (A5481003) Phase I/II, Open-Label, Randomized Study of the Safety, Efficacy, and Pharmacokinetics of Letrozole Plus PD 0332991 (Oral CDK 4/6 inhibitor) and Letrozole Single Agent, for the First-Line Treatment of ER Positive, HER2 Negative Advanced Breast Cancer in Postmenopausal Women
Principal Investigator: Nicholas Robert, MD
Contact Person: Stacey Banks, 703-208-3148
Open
Mayo Clinic MC0738
The Effect of Anti-depressants and Gabapentin on Tamoxifen Pharmacokinetics: A Prospective Study
Principal Investigator: Neelima Denduluri, MD
Contact Person: Stacey Banks, 703-208-3148
Open