Clinical Trials Actively Recruiting Patients With Breast Cancer

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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




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, 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, 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, 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, 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 ­ record for study locations and contacts 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, Identifier: NCT01191580   ■


Editor’s Note: The clinical trials presented here do not represent all the trials listed on For the complete list, go to