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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, Los Angeles, CA
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., and Abenaa Brewster, MD, MD Anderson Cancer Center, Houston, TX
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., University of Massachusetts, Amherst, Amherst, MA
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 Early Detection of Epithelial Ovarian Cancer Using Exhaled Breath Markers
Researcher Michael McCulloch, LAc, MPH, PhD, Pine Street Foundation, San Anselmo, CA
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, Washington University School of Medicine, St. Louis, MO
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, Miami, FL
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 The Jewels in Our Genes Study
Researcher Heather Ochs-Balcom, PhD, University at Buffalo, Buffalo, NY
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 Variations in the Health Needs of Breast Cancer Survivors (Lesbian/Bisexual Survivors)
Researcher Ulrike Boehmer, PhD, 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 Breast Cancer, Uterine Cancer, and YOU Study
Researcher Michael Milam, MD, MPH, University of Louisville Brown Cancer Center, KY
Study Abstract The research hypothesis of this proposal is that there are distinct pathologic and clinical characteristics in women with breast cancer that significantly increases their risk for subsequent uterine cancer. By identifying these modifiable characteristics we can improve clinical care, thus improving the health of these women by allowing them to avoid the unnecessary morbidity and potential mortality of subsequent uterine cancer. Using a case-control study design we will administer surveys aiming to predict which patients are at risk for developing uterine cancer, potentially improving survival for these breast cancer patients. To realize this goal the current study has the following specific aims:
First Objective: Determine the specific pathologic and clinical characteristics that significantly increases the odds a woman with breast cancer subsequently develop uterine cancer.
Second Objective: Test the feasibility and acceptability of tests predicting risk of uterine cancer in women with breast cancer
Project Title Inflammation Changes Over Time In Obese, Overweight, and Normal Weight Women
Researcher Edward Sauter, MD, PhD, M.H.A., University of North Dakota School of Medicine & Health Sciences, Grand Forks, ND
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, Georgetown University, Washington, DC
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 Effects of Birth Control Pills on Breast Tissue
Researcher Anna Wu, PhD, Heather Macdonald, MD, Claire Templeman, MD, Linda Hovanessian-Larsen, MD, Michael Press, MD, Debra Howes, MD, Frank Stanczyk, PhD, Malcolm Pike, PhD, and C. Leigh Pearce, PhD, University of Southern California, Los Angeles, CA
Study Abstract Experimental and epidemiological studies show that both estrogens (e.g. EE2) and progestins (e.g. NET) can increase breast‐cell proliferation but the dose response has not been well studied as it relates to either hormone and our understanding is very incomplete. Epidemiological studies have not convincingly shown any dose‐effect relationships with the components of oral contraceptives (OCs) and breast cancer risk; however, retrospective studies of history of OC use suffer from great errors of recall of OC brand, in particular of dose of estrogen and progestin in the OC, and this problem is aggravated by the fact that many women have used many brands (and doses) of OC. The aim of this study is to continue our efforts to remedy this lack of reliable information by studying the effects of changing the dose of EE2 and the dose of a commonly prescribed progestin, norethisterone (NET), on breast‐cell proliferation in healthy volunteers ages 18 to 35 by providing the OC for three months of use and obtaining a small amount of breast tissue for immunohistochemistry and microdissection to separate out the various tissue types to be analyzed by microarray analysis on commercially available affymetrix chips.
Project Title Interpersonal Therapy for Depression in Breast Cancer Study
Researcher Carlos Blanco, MD, PhD, New York State Psychiatric Institute/Columbia University, New York, NY
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 Latina Breast Cancer Initiative
Researcher Annette Stanton, Ph.D., and Betina Yanez, Ph.D., University of California, Los Angeles
Study Abstract This study seeks to investigate psychological and physical adjustment to a breast cancer diagnosis in a diverse sample of Latina women by testing the predictive utility of a theoretically grounded and culturally-relevant model of determinants of adjustment to breast cancer in a sample of Latina women from diverse socioeconomic backgrounds. Determinants of adjustment include acculturation, coping, surgical treatment consequences, life stress, illness beliefs, and efficacy in patient-physician communication. Adjustment will be indicated by psychological (e.g., clinically significant depression, cancer-specific distress) and physical (e.g., fatigue) indexes of quality of life. Women will complete an initial assessment within one year of diagnosis and a follow-up assessment three months later in order to measure change in adjustment. All interviews will be conducted by phone.
Project Title Effects of Soy on Breast Tissue Study
Researcher Anna Wu, PhD, Augustin Garcia, MD, Debra Hawes, MD, Linda Hovanessian-Larsen, MD, Heather McDonald, MD, Sue Ellen Martin, MD, Malcolm Pike, MD, Pulin Sheth, MD, Darcy Spicer, MD, and Debu Tripathy, MD, at the University of Southern California
Study Abstract The overall objective of this translational project is to determine whether women diagnosed with DCIS or invasive breast cancer who are not under treatment or have completed treatment benefit from soy supplementation. We will evaluate whether there are significant beneficial changes from baseline in MRI volume, and markers of breast cell proliferation and apoptosis in the breast of ‘high-risk’ women who are randomized to soy compared to placebo for 1 year. Specifically, we will assess whether:
1) magnetic resonance imaging (MRI) volume (equivalent to 3-dimensional mammographic density) is reduced in high-risk women or those with breast cancer who are supplemented daily with soy (each tablet contains 50 mg total isoflavones as aglycone) compared to placebo tablets for 1 year.
2) cell proliferation and apoptosis, as measured by Ki67 and caspase 3 staining, respectively, of breast epithelial cells is altered with soy treatment.
Project Title Vitamin D3 Effects on Musculoskeletal Symptoms with Use of Aromatase Inhibitors (D3AI)
Researcher Alice Shapiro, PhD, RD, LN and the Oncology Research Team at Park Nicollet Health Services and the University of Minnesota
Study Abstract This pilot project will enroll women with a history of breast cancer who have no evidence of current disease and experience aromatase inhibitor-associated musculoskeletal symptoms in a double-blind randomized clinical trial. The trial will compare vitamin D3 supplementation at the RDA of 600 IU/day (Control group) to the upper tolerable, safe level of 4,000 IU/day (Experimental group). Both groups will also receive 500 mg calcium carbonate per day. The specific aims of the project are to determine the efficacy of vitamin D3 in reducing musculoskeletal symptoms by comparing the change in symptoms from baseline to 6 months in women who are in the experimental group as compared with the usual care control group, to determine whether supplemental vitamin D3 improves adherence to aromatase inhibitor treatment, and to measure changes in circulating sex hormone levels and serum aromatase inhibitor concentration in both groups during the trial.
Project Title Sister Survivor: Improving the Survivorship Care of African-American Women with Breast Cancer
Researcher Kimlin Ashing-Giwa, PhD, City of Hope, and the African American Breast Cancer Coalition
Study Abstract The research team will implement and evaluate the impact of a multilevel peer navigator (PN) intervention for African-American breast cancer survivors (AABCS) on comprehension of and adherence to survivorship care plan (SCP).
25 PN will be trained to provide navigation to AABCS. 120 participants will be randomized to either PN intervention (n=60) or control (n=60) conditions. The peer navigation sessions will be delivered via face-to face or by telephone. The Peer Navigator trial is accomplished through 5 processes: 1) Information: PN provide education and resources about the effects of breast cancer and its treatments, care planning, physical functioning; 2) Patient activation: coaching in medical efficacy and communication; 3) Providing support: PN listen, share, and attend to the human side; 4) Access: facilitate utilization of healthcare resources/services, access to SCP; 5) Coordination: facilitate utilization of healthcare, adherence to SCP.
Project Title Discovery of Early Markers of Breast Cancer (Phase 2)
Researcher Isabelle Bedrosian, MD, and Abenaa Brewster, MD, MD Anderson Cancer Center, Houston, TX
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 Breast Cancer Cognitive Rehabilitation Study
Researcher Patricia Ganz, MD, UCLA Jonsson Comprehensive Cancer Center, and Linda Ercoli, PhD, Steven Castellon, PhD, and Andrew Luechter, MD, UCLA Semel Institute
Study Abstract There is an emerging body of data supporting the existence of cognitive difficulties associated with cancer treatments. The mechanisms responsible for the development of these difficulties are multi-factorial and may potentially be related to direct treatment toxicity, but are also associated with other factors including stress, hormonal and immune exposures, and even predisposing cognitive impairments. While work is underway in our laboratory and in other groups to understand the biological mechanisms associated with the risk of cognitive complaints after breast cancer treatments, there are a substantial number of women who have persistent difficulties with memory, concentration, multi-tasking and other activities, such that rehabilitative interventions need to be developed to help them recover and adjust to these post-treatment difficulties. To the best of our knowledge, there has been only one research group that has developed such a program, and this focused on individual treatment. As part of our BCRF funded research program, we are conducting a randomized, wait-list control, Phase II trial that will evaluate the feasibility and preliminary efficacy of a specially designed cognitive rehabilitation intervention for breast cancer survivors. Sixty breast cancer survivors who have cognitive complaints and have completed their primary cancer treatment (i.e., surgery, radiation, and/or chemotherapy; 18 months to 5 years ago) will be enrolled and randomized into the intervention group or to a wait-list control group. Participants will complete questionnaires, have two QEEG procedures before and after the 5-week intervention, complete neuro-cognitive testing once before and two times after the 5-week intervention.
Project Title Variations in the Health Needs of Breast Cancer Survivors (Phase 2)
Researcher Ulrike Boehmer, PhD, 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.
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