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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 2014

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.


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
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; Maria Agra, RN, 703-720-5210
Open
Alliance A011106
Alternate Approaches for Clinical Stage II or III Estrogen Receptor Positive Breast Cancer Neoadjuvant Treatment (ALTERNATE) in Postmenopausal Women: A Phase III Study
Principal Investigator:Mary Wilkinson, MD
Contact Person: Maria Agra, RN, 703-720-5210
Open
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
Principal 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
SWOG S1207
Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer
Principal Investigator: Mary Wilkinson, MD
Contact Person: Maria Agra, RN, 703-720-5210
Open
Alliance A221101
Randomized Double-Blind Placebo Controlled Study of Subcutaneous Testosterone in the Adjuvant Treatment of Postmenopausal Women with Aromatase Inhibitor Induced Arthralgias
Principal Investigator: Mary Wilkinson, MD
Contact Person: Maria Agra, RN, 703-720-5210
Open
SWOG 1202
A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor Associated Musculoskeletal Symptoms in Women with Early Stage Breast Cancer
Principal Investigator: Mary Wilkinson, MD
Contact Person: Maria Agra, RN, 703-720-5210
Open
Pfizer A5481023
A Multicenter Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Fulvestrant (Faslodex®) with or without PD-03232991 (Palbociclib) +/- Goserelin in Women with Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer Whose Disease Progressed after Prior Endocrine Therapy
Principal Investigator: Mary Wilkinson, MD
Contact Person: Maria Agra, RN, 703-720-5210
Open
Side-Out Foundation SO-BCA-0002 Side-Out 2 A Pilot Study Utilizing Proteomic and Genomic Profiling by Reverse Phase Protein Microarray (RPMA), IHC Analysis, RNA-Seq, and Exome Sequencing of Patients' Tumors to Find Potential Targets and Select Treatments for Patients with Metastatic Breast Cancer
Principal Investigator: Nicholas Robert, MD
For more information on this clinical trial, call 703-208-3192
Open
Novartis
CBKM120F2202
A Randomized, Double-Blind, Placebo Controlled, Phase II Study of BKM120 Plus Paclitaxel in Patients with HER2 Negative Inoperable Locally Advanced or Metastatic Breast Cancer, with or without PI3K Pathway Activation
Principal Investigator: Mary Wilkinson, MD
Contact Person: Maria Agra, RN 703-720-5210
 Open
NSABP B-43
A Phase III Clinical Trial Comparing Trastuzumad Given Concurrently with Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy
Principal Investigator: Mary Wilkinson, MD
Contact Person: Maria Agra, RN 703-720-5210
 Open
USO 11-027 BELLE 4
A Randomized, Double-Blind, Placebo Controlled Phase II/III Study of BKM120 Plus Paclitaxel in Patients with HER2 Negative Inoperable Locally Advanced or Metastatic Breast Cancer, with or without PI3K Pathway Activation
Principal Investigator: Neelima Denduluri, MD
For more information on this clinical trial, call 703-208-3192
 Open
USO 13-204
Phase 1 Study of Mifepristone in Combination with Eribulin in Patients with Locally Advanced/Metastatic Breast Cancer with a Dose Expansion Cohort in Patients with Triple Negative Breast Cancer
Principal Investigator: Alex Spira, MD, PhD, FACP
For more information on this clinical trial, call 703-208-3192
 Open
USOR 13-053
A Phase Ib/II Clinical Study of BBI608 Administered with Paclitaxel in Adult Patients with Advanced Malignancies
Principal Investigator: Alex Spira, MD, PhD, FACP
For more information on this clinical trial, call 703-208-3192
 Open
Galena/Genentech ML 25749
Combination Immunotherapy with Herceptin and the HER2 Vaccine E75 in Low and Intermediate HER2-Expressing Breast Cancer Patients to Prevent Recurrence
Principal Investigator: Nicholas J. Robert, MD
For more information on this clinical trial, call 703-208-3192
 Open
USOR 13-111
A Phase 3, Open-Label, Randomized, Parallel, 2-Arm, Multi-Center Study of BMN 673 versus Physician's Choice in Germline BRCA Mutation Subjects with Locally Advanced and/or Metastatic Breast Cancer, Who Have Received No More than 2 Prior Chemotherapy Regimens for Metastatic Disease
Principal Investigator: Nicholas J. Robert, MD
For more information on this clinical trial, call 703-208-3192
 Open
USO 13-128
A Multicentered, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Fulvestrant (Faslodex®) with or without PD-0332991 Palbociclib +/- Goserelin in Women with Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer Whose Disease Progressed after Prior Endocrine Therapy
Principal Investigator: Nicholas J. Robert, MD
For more information on this clinical trial, call 703-208-3192
 Open
USO 13-146
A Randomized Double-Blind, Placebo-Controlled Study of LEE011 in Combination with Letrozole for the Treatment of Postmenopausal Women with Hormone Receptor Positive, HER2-Negative, Advanced Breast Cancer who Received No Prior Therapy for Advanced Disease
Principal Investigator: Anne Favret, MD
For more information on this clinical trial, call 703-208-3192
 Open
Galena Biopharma PH3-01 "PRESENT"

A Efficacy and Safety Study of NeuVax™ Vaccine to Prevent Breast Cancer Recurrence
Principal Investigator: Nicholas J. Robert, MD
For more information on this clinical trial, call 703-208-3192
 Open
USO 11-143
A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase II Trial Evaluating the Safety and Efficacy of TKI258 Combined with Fulvestrant, in Postmenopausal Patients with HER2- and HR+ Breast Cancer that Have Evidence of Disease Progression on or after Prior Endocrine Therapy
Principal Investigator: Neelima Denduluri, MD
For more information on this clinical trial, call 703-208-3192
 Open