The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies for patients with breast cancer. The trials are investigating cancer risk based on breast density; novel imaging techniques; fasting and chemotherapy; radiosurgery; lymph node dissection; and interpersonal therapy for depression. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.
Observational
Study Type: Observational
Study Title: Longitudinal Changes in Mammographic Density and Risk of Breast Cancer
Study Sponsor and Collaborators: Case Comprehensive Cancer Center, National Cancer Institute
Purpose: To study changes in breast density and gathering health information over time to assess breast cancer risk in women with breast cancer and in healthy women
Primary Outcome Measures: Within-individual mammographic density (MD) longitudinal change and breast cancer risk, patterns of within-individual longitudinal change in MD, predictors of across-individual differences in MD change [time frame: cancer cases diagnosed within the last 3 years (2004–2006)]
Principal Investigator: Li Li, MD, PhD, and Cheryl Thompson, PhD, Case Medical Center/University Hospitals Seidman Cancer Center/Case Comprehensive Cancer Center; 216-844-3944, lili@uhhospitals.org
ClinicalTrials.gov Identifier: NCT00445445
Phase I
Study Type: Phase I/interventional/single-group assignment
Study Title: FBnTP Positron Emission Mammography Imaging of Mitochondria Function–Breast Cancer
Study Sponsor and Collaborators: Sidney Kimmel Comprehensive
Cancer Center
Purpose: To study the capacity of the positron emission tomography imaging agent 18F-fluorobenzyl triphenyl phosphonium (FBnTP) to detect early-stage small breast tumors (eg, DCIS) and differentiate benign from malignant masses with better accuracy than that obtained by existing breast imaging tools
Primary Outcome Measures: Malignant breast cancer detection [time frame: pretreatment]
Principal Investigator: Igal
Madar, PhD, Johns Hopkins University; contact John Crandall, 410-502-2186, jcranda1@jhmi.edu
ClinicalTrials.gov Identifier: NCT02204462
Phase I/II
Study Type: Phase I/II/interventional/single-group assignment
Study Title: A Pilot Study of Short-term Fasting on Neoadjuvant Chemotherapy in Patients With Newly Diagnosed Breast Cancer (STEFNE Study)
Study Sponsor and Collaborators: Western Regional Medical Center
Purpose: To study how safe the use of short-term fasting is in breast cancer patients who will receive chemotherapy before undergoing surgery and to examine if the use of short-term fasting will decrease the side effects of chemotherapy and how much a tumor shrinks while receiving chemotherapy
Primary Outcome Measures: Evaluate pathologic complete remission rate at the time of surgery or partial pathologic response rate (defined as residual invasive disease of 1cm) at the time of surgery or at the time of biopsy upon completion of planned chemotherapy [time frame: 4–6 cycles (up to 12 weeks)]
Principal Investigator: Jiaxin Niu, MD, PhD, Western Regional Medical Center; contact 623-207-3000, westerntrials@ctca-hope.com
ClinicalTrials.gov Identifier: NCT02379585
Phase II
Study Type: Phase II/interventional/single-group assignment
Study Title: A Phase II Study of Stereotactic Radiosurgery Plus HER2 Directed Therapy in HER2-Positive Breast Cancer With Brain Metastasis
Study Sponsor and Collaborators: University of Maryland
Purpose: To determine if treatment with stereotactic radiosurgery followed by a HER2-directed therapy regimen results in a 6-month distant brain relapse rate of less than 30%
Primary Outcome Measures: Relapse rate (primary) [time frame: 12 months]
Principal Investigator: Elizabeth Nichols, MD, University of Maryland Baltimore; contact Bahiyyah Jackson, MS, 410-328-7586, bjackson1@umm.edu
ClinicalTrials.gov Identifier: NCT01924351
Phase III
Study Type: Phase III/interventional/parallel assignment
Study Title: A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy
Study Sponsor and Collaborators: Alliance for Clinical Trials in Oncology, National Cancer Institute
Purpose: To study axillary lymph node dissection to see how well it works compared to axillary radiation therapy in treating patients with node-positive breast cancer treated with neoadjuvant chemotherapy followed by surgery
Primary Outcome Measures: Invasive breast cancer recurrence-free interval (IBC-RFI) [time frame: up to 5 years after completion of radiation therapy]
Principal Investigator: Judy Boughey, MD, Mayo Clinic; see ClinicalTrials.gov record for study locations and contacts
ClinicalTrials.gov Identifier: NCT01901094
Phase IV
Study Type: Phase IV/interventional/parallel assignment
Study Title: Interpersonal Therapy for Depression in Breast Cancer
Study Sponsor and Collaborators: New York State Psychiatric Institute
Purpose: To compare the efficacy of interpersonal psychotherapy (IPT), problem-solving therapy (PST), and brief supportive psychotherapy (BSP), in improving depressive symptoms, psychosocial functioning, and quality of life among patients with breast cancer and major depressive disorder
Primary Outcome Measures: Hamilton Depression Scale (HAMD-17) [time frame: weeks 1, 4, 8, 12, 16, 24, 32]
Principal Investigator: Carlos Blanco, MD, PhD, New York State Psychiatric Institute; 646-774-8111, cb255@columbia.edu
ClinicalTrials.gov Identifier: NCT01191580 ■
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.
