The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on patients with breast cancer. These studies highlight neoadjuvant combination therapy, cell vaccines, novel imaging techniques, radiotherapy, and more. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.
Phase I
Study Title: Phase I Dose-Escalation Study of Combination of Gedatolisib With Palbociclib and Fulvestrant in the Neoadjuvant Setting in Previously Untreated Patients With Estrogen Receptor–Positive/HER2-Negative Breast Cancer
Study Type: Phase I/interventional/single-group assignment
Study Sponsor and Collaborators: Eastchester Center for Cancer Care
Purpose: To study the effect of the neoadjuvant gedatolisib with palbociclib and fulvestrant in previously untreated patients with estrogen receptor–positive/HER2-negative breast cancer
Primary Outcome Measures: Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [time frame: 12–24 months]
Principal Investigator: Anthony Hoffman, MD, Eastchester Center for Cancer Care; (718) 732-4000, anthony@eastchestercenter.com
ClinicalTrials.gov Identifier: NCT02626507
Study Title: Pilot Trial of Type I-Polarized Autologous Dendritic Cell Vaccine Incorporating Tumor Blood Vessel Antigen–Derived Peptides in Patients With Metastatic Breast Cancer
Study Type: Phase I/interventional/single-group assignment
Study Sponsor and Collaborators: Case Comprehensive Cancer Center
Purpose: To study the safety of a dendritic cell vaccine when given with gemcitabine hydrochloride in treating patients with breast cancer that has spread beyond the breast and local lymph nodes to other organs in the body
Primary Outcome Measures: Number of toxicities [time frame: 30 days after completion of the study]
Principal Investigator: Joseph Baar, MD, PhD, Case Comprehensive Cancer Center; (216) 844-8571, joseph.baar@uhhospitals.org
ClinicalTrials.gov Identifier: NCT02479230
Study Title: Imaging of in Vivo Sigma-2 Receptor Expression With [18F]ISO-1 Positron-Emission Tomography (PET/CT) in Primary Breast Cancer
Study Type: Phase I/interventional/single-group assignment
Study Sponsor and Collaborators: University of Pennsylvania
Purpose: To use PET/CT imaging to evaluate sigma-2 receptor activity in the sites of primary breast cancer using the investigational radiotracer [18F]ISO-1
Primary Outcome Measures: Correlate [18F]ISO-1 uptake with assays measuring cellular proliferation rates [time frame: 2 years]
Principal Investigator: Elizabeth McDonald, MD, PhD, and David Mankoff, MD, PhD; contact Karen Palmer, (215) 746-2813, karen.palmer@uphs.upenn.edu
ClinicalTrials.gov Identifier: NCT02284919
Phase II
Study Title: Hypofractionated, Comprehensive Radiation Therapy for Node-Positive Breast Cancer
Study Type: Phase II/interventional/single-group assignment
Study Sponsor and Collaborators: University of Colorado, Denver
Purpose: To learn more about a particular dose of radiation treatment for breast cancer that is completed in a shorter amount of time than what has traditionally been used to treat breast cancer
Primary Outcome Measures: Number of participants with treatment-related adverse events as assessed by CTCAE version 4.03; lymphedema severity by measuring interlimb circumference; symptomatic rib fracture as measured by plain film or CT; new development of ischemic heart disease as measured by electrocardiogram; shoulder stiffness as measured by the European Organisation for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC QLQ-C3014) and breast-cancer module (BR23) [time frame: up to 60 months]
Principal Investigator: Christine Fisher, MD, MPH, University of Colorado, Denver; contact Dr. Fisher, (720) 848-0154, christine.fisher@ucdenver.edu
ClinicalTrials.gov Identifier: NCT02700386
Study Title: A Prospective Single-Arm Phase II Study to Investigate the Efficacy of Single-Fraction Intraoperative Radiation Treatment Using a Multilumen Balloon Applicator and In-Room CT Imaging for the Treatment of Early-Stage Breast Cancer
Study Type: Phase II/interventional/single-group assignment
Study Sponsor and Collaborators: University of Virginia
Purpose: To evaluate an investigational way to provide radiation therapy to treat early-stage breast cancer at the time of surgery
Primary Outcome Measures: Rate of local breast tumor recurrence [time frame: up to 60 months after treatment]
Principal Investigator: Shayna Showalter, MD, University of Virginia; contact Katie Rea, RN, (434) 243-3015, kaw3j@hscmail.mcc.virginia.edu
ClinicalTrials.gov Identifier: NCT02400658
Study Title: Women’s Triple-Negative First-Line Study: A Phase II Trial of Mirvetuximab Soravtansine in Patients With Localized Triple-Negative Breast Cancer With Tumors Predicted Insensitive to Standard Neoadjuvant Chemotherapy
Study Type: Phase II/interventional/parallel assignment
Study Sponsor and Collaborators: MD Anderson Cancer Center, National Comprehensive Cancer Network
Purpose: To learn whether mirvetuximab soravtansine can help to control either newly diagnosed or metastatic triple-negative breast cancer
Primary Outcome Measures: Response rate of mirvetuximab soravtansine in participants with metastatic folate receptor alpha–positive triple-negative breast cancer [time frame: 6 months]; pathologic response of mirvetuximab soravtansine in participants with chemotherapy-insensitive, folate receptor alpha–positive triple-negative breast cancer [time frame: 12 weeks]
Principal Investigator: Stacey Moulder, MD, MD Anderson Cancer Center; (713) 563-0730, CR_Study_Registration@mdanderson.org
ClinicalTrials.gov Identifier: NCT03106077 ■
Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.
