Clinical Trials Actively Recruiting Patients With Breast Cancer

Study Type: Phase I/II interventional/nonrandomized/single-group assignment

Study Title: A Phase I/II Trial of Short Course Preoperative Ritonavir to Determine Akt Inhibition in Breast Cancer

Study Sponsor and Collaborators: Masonic Cancer Center, University of Minnesota; Susan G. Komen Breast Cancer Foundation

Purpose: To study the best dose of ritonavir and its effects on biomarkers in women undergoing surgery for newly diagnosed breast cancer

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Female

Accepts Health Volunteers: No

Primary Outcome Measures: Inhibition of breast cancer by targeting Hsp90-Akt pathway (time frame: pre- and post-treatment)

Principal Investigator: David A. Potter, MD, PhD, Masonic Cancer Center, University of Minnesota, 612-625-8933, dapotter@umn.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01009437

Study Title: A Randomized, Open-Label Comparative Study of Combination Therapy With Cyclophosphamide and an Allogeneic GM-CSF-secreting Breast Tumor Vaccine With or Without Trastuzumab for the Treatment of Metastatic Breast Cancer That Does NOT Overexpress HER-2/Neu

Study Sponsor and Collaborators: Sidney Kimmel Comprehensive Cancer Center; National Cancer Institute

Purpose: To study the side effects of giving cyclophosphamide together with vaccine therapy and to see how effective it is compared with giving cyclophosphamide and vaccine therapy together with trastuzumab in treating patients with metastatic breast cancer

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Toxicity as assessed by NCI CTCAE v3.0 (time frame: 3 years)

Principal Investigator: Leisha A. Emens, MD, PhD, Sidney Kimmel Comprehensive Cancer Center. Contact: Maureen Berg, RN, OCN, 443-287-6602, mberg1@jhmi.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00971737

Study Type: Interventional/randomized

Study Title: A Cluster Randomized Controlled Trial Comparing Interventions to Enhance Utilization of Genetics Services Among Breast Cancer Patients

Study Sponsor and Collaborators: University of South Florida; National Cancer Institute

Purpose: To compare active and passive interventions to increase the rate of appropriate genetic counseling referrals of newly diagnosed breast cancer patients at increased risk for hereditary breast and ovarian cancer (HBOC) to genetic counseling in the community oncology setting.

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Female

Accepts Health Volunteers: No

Primary Outcome Measures: Rate of appropriate referral of newly diagnosed breast cancer at increased risk for HBOC to genetic counseling in active vs passive intervention clusters (time frame: 1 year postdiagnosis)

Principal Investigator: Rebecca Sutphen, MD, 800-909-1242, ccop@epi.usf.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01789684

Study Type: Interventional/single-group assignment

Study Title: A Pilot Study of the Immunogenicity of a 9-Peptide Breast Cancer Vaccine Plus Poly-ICLC in Stage IB-IIIA Breast Cancer

Study Sponsor and Collaborators: University of Virginia

Purpose: To determine whether a vaccine consisting of nine class I breast-specific peptides plus a class II tetanus toxoid helper peptide is immunogenic when administered with poly-ICLC to participants with stage IB to IIIA breast cancer in the adjuvant setting

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Frequency of dose-limiting adverse events

Principal Investigator: Patrick M. Dillon, MD, University of Virginia. Contact: Emily Allred, PhD, 434-982-1902, eh4m@hscmail.mcc.virginia.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01532960

Study Title: Light-Scattering Spectroscopy for the Detection of Stage II-III Breast Cancer: A Pilot Study

Study Sponsor and Collaborators: University of Southern California; National Cancer Institute

Purpose: To investigate light-scattering spectroscopy in finding disease in patients with stage II-III breast cancer

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Female

Accepts Health Volunteers: Yes

Primary Outcome Measures: Accurate classifications of women with or without breast cancer (time frame: up to 1 year)

Principal Investigator: Jacques Van Dam, MD, PhD, University of Southern California. Contact: Victoria Soto, 323-226-6384, Victoria.soto@med.usc.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01755208

Study Type: Observational

Study Title: Helping Ourselves, Helping Others: The Young Women’s Breast Cancer Study

Study Sponsor and Collaborators: Dana-Farber Cancer Institute

Purpose: Investigators are conducting a longitudinal cohort study of women age 40 and younger with newly diagnosed breast cancer. The study is investigating short- and long-term disease and treatment issues, tumor biology and the relationship to patient outcomes, and psychosocial concerns at baseline and in follow-up among these patients.

Ages Eligible for Study: 18 to 40 years

Genders Eligible for Study: Female

Accepts Health Volunteers: No

Primary Outcome Measures: Identify a cohort of young women newly diagnosed with breast cancer (time frame: 10 years)

Principal Investigator: Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute; 617-632-3800, ahpartridge@partners.org

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01468246

Study Title: Genome-Wide Association Study of Radiation Exposure and Bilateral Breast Cancer

Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer Center; Translational Genomics Research Institute, University of Southern California, University of Virginia, Lund University, Ontario Cancer Registry and Mount Sinai Hospital-Toronto, Northern California Cancer Center, Fred Hutchinson Cancer Research Center, University of Iowa, Danish Cancer Society, Beckman Research Institute, City of Hope National Medical Center, MD Anderson Cancer Center, Vanderbilt University School of Medicine, New York University School of Medicine, University of Chicago, University of California, Irvine, Stanford University

Purpose: To determine what factors may be related to the risk of getting a second breast cancer among women who already have the disease in one breast. The results of the study may help to develop better ways to detect, treat, and prevent breast cancer.

Ages Eligible for Study: 18 to 54 years

Genders Eligible for Study: Female

Accepts Health Volunteers: No

Primary Outcome Measures: Identify single nucleotide polymorphism that interact with radiation exposure (time frame: 2.5 years)

Principal Investigator: Jonine Bernstein, PhD, Memorial Sloan Kettering Cancer Center, 646-735-8155

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00903591

Study Type: Observational

Study Title: Spousal Relationships and Pain in Metastatic Breast Cancer

Study Sponsor and Collaborators: MD Anderson Cancer Center; Department of Defense

Purpose: The aims of this study are to examine patient pain, spouse response to patient pain, and patient behaviors in response to pain over the course of 6 months in couples facing metastatic breast cancer; test the biopsychosocial model of chronic pain in breast cancer; and use ecologic momentary assessment to characterize patient pain, spouse response to patient pain, and patient behaviors in response to pain.

Ages Eligible for Study: N/A

Genders Eligible for Study: Both

Accepts Health Volunteers: Yes

Primary Outcome Measures: Longitudinal assessment of the psychological and relationship functioning of metastatic breast cancer and their spouses (time frame: 6 months)

Principal Investigator: Hoda Badr, PhD, MD Anderson Cancer Center, 713-792-5922

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00386620

Study Type: Observational

Study Title: Breast Cancer Molecular Analysis Prior to Investigational Therapy

Study Sponsor and Collaborators: Yale University; Foundation Medicine

Purpose: To find defects in the DNA of the cancer that could potentially be treated with FDA-approved or investigational drugs

Ages Eligible for Study: N/A

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Molecular analysis of metastatic breast cancer using DNA sequencing (time frame: 2 years)

Principal Investigator: Lajos Pusztai, MD, Yale University. Contact: Noelle Sowers, RN, 203-737-3472, noelle.sowers@yale.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01855503

Study Title: Breast Cancer and the Workforce: Ethnic Differences in the Impact of Breast Cancer on Employment Status, Financial Situation, and Quality of Life

Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer Center; The City College of New York, Lincoln Medical and Mental Health Center, New York Hospital Queens, Ralph Lauren Center for Cancer Care and Prevention, New York City Health and Hospitals Corporation, Queens Medical Associates

Purpose: To learn more about how being treated for breast cancer affects patients’ employment, financial situation, and quality of life on both a short- and long-term basis

Ages Eligible for Study: 18 to 64 years

Genders Eligible for Study: Female

Accepts Health Volunteers: Yes

Primary Outcome Measures: To compare the impact of breast cancer on employment status, financial situation, and quality of life (time frame: 3 years)

Principal Investigator: Victoria Blinder, MD, MSc, Memorial Sloan Kettering Cancer Center, 646-888-4808

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01134172

Study Title: Developing In Vivo Models of Human Breast Cancer

Study Sponsor and Collaborators: Vanderbilt-Ingram Cancer Center; National Cancer Institute

Purpose: To develop mouse models of breast cancer using tissue samples that were previously collected from women with breast cancer

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Female

Accepts Health Volunteers: No

Primary Outcome Measures: Development of new in vivo models of human breast cancer (time frame: 1 year)

Principal Investigator: A. Bapsi Chakravarthy, MD, Vanderbild-Ingram Cancer Center, 800-811-8480

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00897468

Study Title: Longitudinal Changes in Mammographic Density and Risk of Breast Cancer

Study Sponsor and Collaborators: Case Comprehensive Cancer Center; National Cancer Institute

Purpose: This natural history study is investigating changes in breast density and gathering information over time to assess breast cancer risk in women with breast cancer and in healthy women.

Ages Eligible for Study: 50 years and older

Genders Eligible for Study: Female

Accepts Health Volunteers: Yes

Primary Outcome Measures: Within individual mammographic density longitudinal change and breast cancer risk (time frame: cancer cases diagnosed within the years 2004-2006)

Principal Investigator: Li Li, MD, PhD, Case Comprehensive Cancer Center, 216-844-3944, li.li@uhhospitals.org

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00445445

Study Title: Feasibility, Validation, and Implementation of Genomic Testing for Chemotherapy and Endocrine Sensitivity of HER2 Negative Primary Invasive Breast Cancer (Clinical Stage I to III)

Study Sponsor and Collaborators: MD Anderson Cancer Center; Susan G. Komen Breast Cancer Foundation, Kellogg Company

Purpose: To determine if researchers can use genetic testing on tumor samples to predict if tumors will respond to breast cancer treatments, including chemotherapy or hormonal therapy. The tumor sample will be tested to learn if certain genes are activated in the tumor.

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Female

Accepts Health Volunteers: No

Primary Outcome Measures: Feasibility analysis of genomic predictor from localized invasive breast cancer tumor registry (time frame: 12 months)

Principal Investigator: Stacy Moulder, MD, MD Anderson Cancer Center, 713-792-2817

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01334021

Study Title: MiRNA Profiling of Breast Cancer in Patients Undergoing Neoadjuvant or Adjuvant Treatment for Locally Advanced & Inflammatory Breast Cancer

Study Sponsor and Collaborators: City of Hope Medical Center

Purpose: MiRNA dysregulation has been implicated in breast tumorigenic and non-tumorigenic development. MiRNA profiling of treatment-naive and treatment-exposed breast tumors and sequential samples of blood/serum will allow for identification of miRNA markers of prognosis and as indicators and potential targets for personalized therapies.

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Female

Accepts Health Volunteers: No

Primary Outcome Measures: Performance of miRNA profiling from tumor samples from primary breast tumors (time frame: 3 years after completion of sample collection)

Principal Investigator: George Somlo, MD, City of Hope Medical Center. Contact: Suzanne Swain-Cabriales, RN, 800-826-4673, sswain-cabriales@coh.org

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01231386

Study Title: A Feasibility Study of a Novel Technique to Identify Circulating Breast Cancer Cells in Patients With Metastatic Breast Cancer

Study Sponsor and Collaborators: Sidney Kimmel Comprehensive Cancer Center; National Cancer
Institute

Purpose: To study a new way of identifying circulating breast cancer cells in blood and in pleural or peritoneal fluid in women with metastatic breast cancer

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Female

Accepts Health Volunteers: No

Primary Outcome Measures: Feasibility of novel technique to identify and isolate circulating breast cancer cells (time frame: baseline)

Principal Investigator: Vered Stearns, MD, Sidney Kimmel Comprehensive Cancer Center, 443-287-6547

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00897338 ■