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Current Research Projects
Project Title Effects of Depo Provera on Breast Tissue Study
Researcher Karine Chung, MD, University of Southern California
Study Abstract Births, especially a first birth before the age of 30, provide lasting protection against breast cancer. An appealing chemopreventive strategy is mimicking this protective effect in young women. Progesterone is present at high levels during pregnancy and there is some evidence from epidemiological studies that treatment with this hormone at pregnancy levels may be associated with a reduced risk of breast cancer. We are proposing to reach out to women currently being treated with this hormone, perform a breast biopsy, and determine if this treatment induces the same gene expression changes brought about by a pregnancy.
Project Title Shift Work and Breast Cancer Risk Study
Researcher Carla Finkielstein, PhD, Virginia Polytechnic Institute and State University, Blacksburg, VA
Study Abstract The research aims to better understand the contribution of circadian disruption in breast cancer etiology. The researchers will determine the mechanism by which the core clock tumor suppressor period 2 (Per2) modulates the expression and function of estrogen receptor alpha (ERα). The researchers will identify and validate candidate marker proteins, derived from nightshift worker breast biopsies, showing the greatest differences in Per2-associated expression. In addition, they will establish the relevance of Per2-ERα pathway defects for pathological progression and clinical outcome in patient populations.
Project Title Discovery of Early Markers of Breast Cancer (Phase 1)
Researcher Isabelle Bedrosian, M.D.
Study Abstract Most breast cancer patients have no known antecedent risk factors. Development of tissue based, molecular markers of breast cancer risk would offer a novel means of individualizing risk assessment and may provide new opportunities for prevention. Activation of the DNA damage response (DDR) is an important cellular mechanism for maintaining genomic integrity. We have recently noted that DNA damage is present in histologically normal mammary epithelial cells adjacent to areas of carcinoma, suggesting that DNA damage may be an early molecular marker of malignant transformation that precedes histologic changes. The objective of this study is to evaluate biomarkers of DDR activation in normal breast tissue as predictors of future development of breast cancer. Our primary hypothesis is that activation of the DDR pathway occurs as an early event in breast tumorigenesis and will be positively associated with invasive breast cancer risk.
Project Title Phase Ib Trial of 2nd Generation Designer T Cells in Metastatic Breast Cancer
Researcher Richard Junghans, PhD, MD, Associate Professor of Medicine, Boston University School of Medicine, and Roger Williams Medical Center, Providence, Rhode Island
Study Abstract Hypotheses: that designer T cells offer an immune based alternative to cancer therapies that has the potential to cure metastatic breast cancers; that several components will potentially contribute to an optimal therapeutic anti-tumor agent; that CEA is the optimal platform for a rapid optimization that will allow generalizable lessons over the range of breast cancer antigens.
Specific Aims:
Clinical (existing products):
1. To test efficacy of 2nd gen designer T cells in metastatic breast cancer
2. To test ancillary procedures for improved persistence and activity of infused designer T cells
Advanced Research & Development:
3. To create and test other CIR designs with alternative co-stimulatory domains
4. To create and test CIR with to avoid need for IL2 supplementation in vivo to sustain T cell survival
Clinical (new products):
5. To conduct clinical trials with the new generation products.
Project Title The Milk Study
Researcher Kathleen Arcaro, Ph.D. at the University of Massachusetts, Amherst
Study Abstract Accurate assessment of breast-cancer-risk will benefit most women and analysis of promoter hypermethylation in exfoliated epithelial cells in breast milk provides an ideal opportunity to assess breast-cancer-risk.
Project Title Genomic Markers of Breast Cancer Prevention Induced by hCG in Women at High Risk
Researcher Irma Russo, MD, Fox Chase Cancer Center, Philadelphia, Pennsylvania
Study Abstract This study will test the hypothesis that the genomic profile of breast epithelial cells of asymptomatic nulliparous women carriers of BRCA1 germline mutations is characteristic of such a risk, and that the induction of differentiation by treatment with human chorionic gonadotropin (r-hCG) would revert the “high risk” to a “low risk” signature that would serve as a biomarker indicative of decreased breast cancer risk. Breast epithelial cells will be collected by random periareolar fine needle aspiration from 18 women with BRCA1 mutations. Cells will be cytopathologically evaluated; RNA will be extracted for analysis of gene expression by cDNA microarray, and immunocytochemical determination of cell proliferation by Ki67, ER and PR status, parameters that will serve as a baseline of the “high risk” genomic profile. This knowledge will serve as the basis for establishing novel genomic signatures as intermediate biomarkers for larger preventive clinical trials at the completion of this project.
Project Title The Impact of Colonic Microbiota on Breast Cancer
Researcher Ece Mutlu, MD, Rush University Medical Center, Chicago, Illinois
Study Abstract The purpose of this study is to find out what type of bacteria can be found in the intestines and to look at the way the bacteria metabolize estrogen and other female hormones. The bacteria of women who have never had breast cancer will be compared to the bacteria of women who have been recently diagnosed with breast cancer. Thirty (30) women who have never had breast cancer are needed for this study.
Project Title Yoga for Breast Cancer Survivors: Effects on Fatigue, Immune Function, and Mood
Researcher Janice Kiecolt-Glaser, PhD, The Ohio State University, Columbus, Ohio
Study Abstract Breast cancer survivors confront a number of post-treatment problems including fatigue, decreased physical function, fears of recurrence, and treatment-related sequelae. Persistent fatigue, the most common and distressing problem, appears to be related in part to overactivation of the inflammatory network.
Project Title Combination of Low-Dose Anti-Estrogens with Omega-3 Fatty Acids for Prevention of Hormone-Independent Breast Cancer
Researcher Andrea Manni, MD, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania
Study Abstract Our hypothesis is that the combination of a low dose of the anti-estrogen raloxifene and the omega-3 fatty acids will exert a synergistic breast cancer chemopreventive effect. This expectation is based on the cooperative mechanisms of action of these two interventions. A unique and attractive feature of our proposed research is that it may identify a prevention strategy that will reduce the development of both hormone-dependent and independent tumors. At present, there are no known interventions able to decrease the development of hormone-independent tumors. In addition, we postulate that this approach will be safe, since it will combine a lower and hence a less toxic dose of raloxifene with the administration of omega-3 fatty acids, which are known to have health benefits. The main objectives of this study are to determine the individual and combined effects of raloxifene and omega-3 fatty acids on surrogate markers of breast cancer development in healthy, postmenopausal women. The primary endpoint will be mammographic density, which is a major risk factor for breast cancer. Secondary endpoints include markers of oxidative stress, parameters of estrogen metabolism, markers of inflammation, and markers of IGF-I signaling.
Project Title Early Detection of Epithelial Ovarian Cancer Using Exhaled Breath Markers
Researcher Michael McCulloch, LAc MPH PhD
Study Abstract Epithelial ovarian cancer is the fifth leading cause of cancer death in women. Early diagnosis is the most important step toward reducing morbidity and mortality from epithelial ovarian cancer. Our laboratories have developed preliminary data suggesting that exhaled breath condensate may provide an important source of biomarkers diagnostic of ovarian cancer. Our primary hypothesis is that using patients with epithelial ovarian cancer can be readily distinguished from both healthy controls and endometriosis or polycystic ovarian syndrome controls, using solely analysis of exhaled breath condensate. We propose this distinction can be made using both sophisticated chemical analysis (GC/FT-ICR MS) and a biological method (canine scent detection).
Project Title Breast Cancer Risk in Young Women Study
Researcher Paul Goodfellow, PhD
Study Abstract Breast cancer takes its greatest toll on young women. Young women frequently have biologically aggressive tumors. They often present with advanced disease and their tumors are frequently hormone non- responsive, thereby limiting treatment options. Young women suffer lower than average disease-free and overall survival. The work proposed is focused on discovery of the as yet unknown genetic risk factors that underlie development of early-onset breast cancer. These findings will pave the way for future studies to elucidate how genetic risk and environmental factors interact and account for the aggressive tumors and poor outcome young breast cancer patients experience. We hypothesize copy number variants (CNVs) play an important role in risk for development of early-onset breast cancer.
Project Title Breast Cancer Microbiota Study
Researcher Ece Mutlu, MD, Rush University Medical Center, Chicago, Illinois
Study Abstract We intend to study the role of the gastrointestinal (GI) microbiota in the pathogenesis of breast cancer (BC) in women. Humans are super organisms that represent a fusion of eukaryotic cells of their own, as well as bacteria and archaea that reside in and over the body, primarily in the GI tract. Little is known about the GI microbiota, which represents the most dense and least diverse ecosystem known on earth. It is believed that GI microbiota is passed on from the mother to her infants and remains fairly stable through life. Bacterial cells in the GI tract outnumber human cells in the body by about 10 fold and carry thousands of additional genes which can rapidly evolve under the pressure of changing environmental factors. The GI tract microbiota approximately weighs about 1 kg in a human being and is estimated to have a metabolic activity comparable to the human liver. A recent metagenomic survey of this activity shows that the bacterial genes for xenobiotics (important in carcinogen and hormone metabolism) are enhanced in the human GI tract.
Project Title Pregnancy and Breast Cancer Risk Study
Researcher Ana Soto, M.D., Tufts University, Boston, MA
Study Abstract The overarching goal of the proposed research is to reveal whether or not the protective role of pregnancy is mediated by the stroma, and if so, whether this effect is mediated through physical properties operating in it. A novel in vitro three-dimensional model of the normal and neoplastic breast will be used to study 1) the role of the parous stroma as mediator of the protective effect of pregnancy on breast carcinogenesis and 2) the contribution of the mechanical forces generated by stromal fibroblasts in this protective process. This research is not only relevant to improving our understanding of the role of the stroma, which has not been studied in detail in humans, but it will open up a new target for prevention and therapy, namely, how to modulate stromal function.
Project Title Project CARE
Researcher Suzanne Lechner, PhD, University of Miami Miller School of Medicine
Study Abstract We previously found that a group-based, cognitive behavioral stress management (CBSM) intervention facilitated psychosocial adaptation after adjuvant therapy in women recently treated for breast cancer by reducing intrusive thoughts, anxiety, social disruption, and negative affect. The intervention also decreased physical symptoms (e.g., fatigue, sleep disruption) and stress markers (e.g., serum cortisol levels), as well as, increased positive affect, benefit finding, and positive states of mind in participants. Such effects held up to one year after surgery. However, the intervention, as is consistent with the larger body of psycho-oncology intervention research, focused primarily on white, middle class women, recruited from private practices and university-based medical centers. The proposed study will address this disparity by adapting our CBSM intervention for Black breast cancer survivors in South Florida, who are grossly underserved in terms of psychosocial needs.
Project Title Acupuncture for Sleep Problems
Researcher David Spiegel, MD, and Oxana Palesh, PhD, MPH, Stanford University School of Medicine
Study Abstract The primary objective of this study is to test the efficacy of acupuncture for reducing sleep disruption in breast cancer survivors.
The secondary objectives of this study include:
• to provide preliminary data on the effects of acupuncture on fatigue and quality of life (QOL) in breast cancer survivors.
• to provide preliminary data on the effects of acupuncture on HPA axis hormones and cytokines in breast cancer survivors.
• to provide preliminary data on how sleep disruption, HPA axis hormones and cytokines in breast cancer survivors effect disease progression.
This study will recruit 64 women diagnosed with breast cancer who finished undergoing treatment and who also experience persistent insomnia problems. The eligible women will be randomized by sleep problems into one of two arms: (Acupuncture vs. Sham Acupuncture) with a goal of having 52 patients complete the study (we anticipate about 20% attrition rate). The placebo control for acupuncture is a validated sham acupuncture. Patients will complete daily diaries, questionnaires, saliva tests and blood draws. Data will be gathered via electronic and pencil-and-paper measures before, during, immediately following and one month following the completion of treatment. In addition, actigraphy data (objective sleep continuity data) will be acquired prior to, during and following treatment.
Project Title The Jewels in Our Genes Study
Researcher Heather Ochs-Balcom, PhD, University at Buffalo
Study Abstract We propose a community-based participatory research-driven, mixed methods and multi-site study that optimizes the recruitment of African American women with breast cancer and their family members to search for novel susceptibility genes. In collaboration with the Witness Project, the goal of this study is to investigate genetic factors related to breast cancer disparities. The aims are: 1) Qualitatively investigate mechanisms to optimize recruitment and participation by African American women; 2) Determine familiality of phenotypic features of breast cancer; and 3) Identify novel genomic regions associated with breast cancer in African American pedigrees with adjustment for differences in genetic ancestry. We will conduct a genome-wide linkage analysis in pedigrees not segregating BRCA1/2 mutations.
Project Title BEAT Cancer Study
Researcher Edward McAuley, PhD, University of Illinois at Urbana Champaign, Urbana, IL and Laura Rogers, MD, MPH, at the Southern Illinois University School of Medicine, Springfield, IL
Study Abstract Most breast cancer survivors do not engage in regular physical activity (PA). Our piloted PA behavior change intervention for breast cancer survivors significantly improved PA and health outcomes post intervention. Testing in additional sites with longer follow-up is warranted to confirm program effectiveness short and longer term. Importantly, the pilot intervention resulted in changes in PA and social cognitive theory constructs, enhancing our potential for testing mechanisms mediating PA behavior change. Therefore, we propose a multicenter, randomized controlled trial enrolling 256 breast cancer survivors with the following study aims:
Primary study aim: To examine intervention effectiveness, the primary study aim is to compare the effects of the BEAT Cancer PA behavior change intervention to usual care on short and longer term PA adherence among breast cancer survivors. We hypothesize that, compared with usual care, the intervention will result in a significant increase in PA adherence post-intervention that will be maintained 3 and 9 months postintervention.
Project Title A Mindfulness Meditation-Based Intervention for Younger Breast Cancer Survivors
Researcher Patricia A. Ganz, MD, Julienne E. Bower, PhD, Annette Stanton, PhD, Sarosh Motivala, PhD, and Catherine Crespi, PhD, at the University of California, Los Angeles School of Medicine
Study Abstract Younger women with breast cancer experience significant levels of stress as a result of their breast cancer diagnosis, in terms of their developmental stage in life, personal and family responsibilities, and the major impact of treatments on reproductive health. As a vulnerable population for long-term effects of cancer treatment on subsequent health and well-being, we are pilot testing a mindfulness meditation group intervention to evaluate its benefits in this population. We are conducting a randomized, wait-list control, Phase II trial that will evaluate the feasibility and preliminary efficacy of a specially designed mindfulness-based intervention on psychological, behavioral, and biological function in younger breast cancer survivors. Sixty breast cancer survivors who were premenopausal at cancer diagnosis and have completed their primary cancer treatment (i.e., surgery, radiation, and/or chemotherapy) will be enrolled and randomized into the intervention group or to a wait-list control group. Participants will complete questionnaires and provide blood samples for immune evaluation before and after the 6-week intervention. In addition, we are obtaining anthropometric measures and collecting data on autonomic function (heart rate variability) and response to a stress evaluation and rumination task.
Project Title Variations in the Health Needs of Breast Cancer Survivors
Researcher Ulrike Boehmer, PhD, at the Boston University School of Public Health, in collaboration with Brown University
Study Abstract The cancer burden is unequally distributed in the population, including the social and emotional impact on those who have received a cancer diagnosis. Sexual minority women (SMW) with breast cancer are recognized as an underserved population, and are assumed to suffer worse cancer outcomes, such as worse quality of life (QOL). We have conducted two studies on this topic, one of which did not find any differences in QOL between SMW and heterosexual breast cancer survivors. Our second study confirmed that SMW have worse QOL after cancer compared to heterosexual women. This inconsistent information hinders future efforts to develop programs to improve SMW's QOL as it is unclear whether there is a need for programs. The purpose of this study is to resolve the inconsistency.
This study has two specific aims: 1. To examine the relationship of patient-derived and cancer-derived factors to QOL among cancer survivors of different sexual orientations. 2. To determine the contribution of sexual minority factors on the QOL of SMW cancer survivors, after patient- and cancer-derived factors have been considered.
Project Title Inflammation Changes Over Time In Obese, Overweight, and Normal Weight Women
Researcher Edward Sauter, MD, PhD, M.H.A.
Study Abstract Overview: Inflammation is present in both individuals with cancer and those who are obese. Inflammation is a process critical to the development and progression of breast cancer. Chronic inflammation is a hallmark sign of obesity. Ovarian hormones influence the expression of proteins involved in multiple pathways.
Hypothesis: Inflammation marker expression will be higher in breast fluid than in the circulating blood; that it will be higher in obese and overweight women compared with normal weight women; and will vary more through the menstrual cycle of premenopausal women compared to postmenopausal women over a 30 day period.
Project Title Stepping STONE (Survivors Taking on Nutrition & Exercise)
Researcher Vanessa Sheppard, PhD, and Lucille Adams-Campbell, PhD, at Georgetown University
Study Abstract The research team is conducting a 12-week two-arm RCT to teach behavioral skills, provide social support and increase women’s self-efficacy in performing positive physical activity (e.g., increase steps per day) and dietary behaviors. In the trial, 120 women will be randomly assigned to either a usual care control (C; n = 60) or intervention (I; n=60) arm. The intervention arm consists of 6 group sessions and 6 individual phone motivational interviewing sessions delivered by a trained peer (survivor coach). At the groups, women will receive an individual PA/dietary “prescription” (e.g., 10,000 steps per day) and group-based physical activity/dietary activities (nutrition demonstrations). Coaches will tailor phone sessions according to survivors’ baseline attitudes, intentions, and social/cultural norms and serve as a source of support. Assessments will occur at 6 weeks and 1 month post intervention.
Project Title ENERGY Study
Researcher Cheryl Rock, PhD, RD; Graham Colditz, MD, DrPH; Wendy Demark-Wahnefried, PhD, RD; and Tim Byers, MD, MPH
Study Abstract We propose a 4-year trial of 800 overweight or obese (BMI >27 and <40 kg/m2) women aged 21 and older who have been diagnosed with stage IC, II, or IIIA breast cancer. The primary specific aim of the project is: (1) To conduct a 4-year vanguard randomized controlled trial with the primary endpoint of weight loss among 800 breast cancer survivors, following all subjects for 2 years after randomization. Our primary hypothesis is that weight loss of at least 7% can be achieved and maintained in this target population. Secondary aims are: (2) To use the Reach, Efficacy/Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to conduct a cost-effectiveness analysis that includes an assessment of the impact of the intervention on medical comorbid conditions; (3) To assess the impact of the intervention on quality of life (QOL), particularly physical functioning and fatigue; and (4) To prospectively collect blood and DNA samples to enable analysis of potential mechanisms and differential response across subgroups.
Project Title Interpersonal Therapy for Depression in Breast Cancer Study
Researcher Carlos Blanco, MD, PhD, New York State Psychiatric Institute/Columbia University
Study Abstract Depressive disorders and symptoms are prevalent in patients with breast cancer, worsen over the course of cancer treatment, persist after cancer therapy, significantly impair quality of life, and decrease adherence to cancer therapy and survival. Yet, there are no established treatments for depression in breast cancer patients. As surviving cancer becomes increasingly common, there is an urgent need to develop an empirical basis to provide effective, evidence-based treatments to this population.
We are conducting a randomized clinical trial to compare the efficacy of Interpersonal Psychotherapy (IPT), Problem-Solving Therapy (PST), and Brief Supportive Psychotherapy (BSP) in alleviating depressive symptoms and improving quality of life for breast cancer patients with DSM-IV major depressive disorder (MDD). In addition to improvement in depressive symptoms, relationships between sociodemographic characteristics, clinical factors, depression treatment adherence, and outcomes care will be examined. Patients in each condition will receive 12 therapy sessions within a 16-week period, and will be followed for another 4 months to examine the stability of response.
Project Title Discovery of Early Markers of Breast Cancer (Phase 2)
Researcher Isabelle Bedrosian, MD, and Abenaa Brewster, MD
Study Abstract Most breast cancer patients have no known antecedent risk factors. Development of tissue based, molecular markers of breast cancer risk would offer a novel means of individualizing risk assessment and may provide new opportunities for prevention. Activation of the DNA damage response (DDR) is an important cellular mechanism for maintaining genomic integrity. We have recently noted that DNA damage is present in histologically normal mammary epithelial cells adjacent to areas of carcinoma, suggesting that DNA damage may be an early molecular marker of malignant transformation that precedes histologic changes. The objective of this study is to evaluate biomarkers of DDR activation in normal breast tissue as predictors of future development of breast cancer. Our primary hypothesis is that activation of the DDR pathway occurs as an early event in breast tumorigenesis and will be positively associated with invasive breast cancer risk.
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