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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, 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 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 Breast Cancer Risk in Young Women Study
Researcher Paul Goodfellow, PhD, The Ohio State University College of Medicine, Columbus, OH, and Jennifer Ivanovich, MS, 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 BEAT Cancer Study
Researcher Edward McAuley, PhD, University of Illinois at Urbana-Champaign, Urbana, IL and Laura Rogers, MD, MPH, at the University of Alabama at Birmingham
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 Inflammation Changes Over Time In Obese, Overweight, and Normal Weight Women
Researcher Edward Sauter, MD, PhD, M.H.A., University of Texas Health Sciences Center in Tyler, Texas
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 Low Dose Tamoxifen Breast Cancer Prevention Study
Researcher Melanie Palomares, MD, MS, City of Hope; Sofia Merajver, MD, PhD, University of Michigan; Melissa Hudson, MD, St. Jude Children's Research Hospital; Ruth O'Regan, MD, Emory University; David Hodgson, Princess Margaret Hospital
Study Abstract The objective of this trial is to test whether a low dose of tamoxifen can have a beneficial effect on breast cancer risk biomarkers in women treated with chest radiotherapy for a prior diagnosis of cancer. Such women have a very high risk of developing breast cancer, approximately 55-times that of an average woman. The standard daily dose of 20mg of tamoxifen has been shown to decrease breast cancer risk by 50%. More recent data suggest that a lower dose of 5mg daily has a similar beneficial effect but with lower side effects. The Low Dose Tamoxifen Breast Cancer Risk Reduction Trial is a placebo-controlled randomized controlled trial of tamoxifen delivered at a reduced dose of 5mg daily for two years. The study is also measuring the safety and tolerability of tamoxifen at the lower dose.
Project Title At-Home Support for Rural Women Using Group Video Calling
Researcher Cheryl Koopman, Ph.D., at Stanford University, Stanford, California, in collaboration with Mary Anne Kreshka, MA, and Joanne Hild, MS, at Sierra Streams Institute, Nevada City, CA
Study Abstract Technological changes offer exciting new opportunities for providing support to women living in rural areas who have been diagnosed with breast cancer. Rural women travel long distances to cancer treatment centers with little or no access to local support groups following treatment. To address this inequality, we will use an at-home delivery system to put women in closer control of their support group accessibility, by providing professionally-led support groups via the Internet, using group video calling. As the Internet is now widely accessible, we propose a pilot study of providing breast cancer support to rural women via group video calling, laying the foundation for a large randomized clinical trial to test this intervention’s efficacy for improving quality of life in this population.
Hypothesis/Questions:
1) Is providing at-home professionally-led support using group video calling acceptable and satisfactory to women diagnosed with breast cancer in California rural communities?
2) Is it feasible to use on-line tools to recruit, screen, assess, randomize, deliver an experimental intervention based on group video calling, and conduct follow-up assessments with these women?
Specific Aims:
1) Demonstrate that delivering at-home professionally-led breast cancer support using group video calling is feasible, acceptable and satisfactory for women in rural California.
2) Evaluate the feasibility of using on-line tools to recruit, screen, treat, and assess this population for a subsequent randomized clinical trial.
3) Assess whether the rate of recruitment of women in this region using predominantly on-line means of recruitment can be improved over that of the previous study using predominantly face-to-face means of recruitment.
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 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 Asian American Community Health Initiative
Researcher Scarlett Lin Gomez, PhD, Cancer Prevention Institute of California
Study Abstract High and rapidly increasing incidence rates of breast cancer among California Asian Americans (AA) have been masked by rates that are traditionally reported for AAs as an aggregated group. Not only do rates vary considerably among AA ethnic subgroups, the research team recently showed that they are high among young US-born women, and rapidly increasing among some US-born and foreign-born groups; for some, rates were even higher than among non-Hispanic white women in California.
The research team will recruit AA controls from the same source population to form a population-based case-control study of breast cancer risk, thereby creating a unique multilevel dataset that will allow them to address the following specific aims: to determine, among controls, 1) the associations between perceived stress and the immigration experience and discrimination, and how these associations are modified by generational status, timing of immigration, and coping styles; 2) how other relevant breast cancer exposures, including age-specific markers of infectious disease exposures, physical activity and body size, and dietary intake and behaviors, vary with generational status and timing of immigration; 3) the extent to which the factors in Aims 1 and 2 vary according to family, social network, and neighborhood characteristics and relationships; and 4) among cases and controls, identify the associations between the factors in Aims 1 and 2 and breast cancer risk among AAs.
Project Title Study of High-Dose Vitamin D Supplementation in Premenopausal Women at High Risk for Breast Cancer
Researcher Katherine Crew, MD, MS, Columbia University, New York, NY
Study Abstract The purpose of this trial is to evaluate the effect of vitamin D on mammographic density (MD) in premenopausal women at high risk of breast cancer, and secondarily to gain information concerning the ability of vitamin D to modulate the expression of breast tissue markers and serum markers. The study has an optional breast biopsy component built in to obtain healthy breast tissue from study participants to investigate the impact vitamin D may have on breast tissue biomarkers. The study uses a double-blind randomization to compare high-dose cholecalciferol of 20,000 IU weekly for one year versus placebo weekly for one year. The main outcome measure of this trial is change in mammographic breast density between mammograms pre-intervention and one-year post intervention.
Southwest Oncology Group (SWOG) is sponsoring the study. The investigators include: Katherine Crew, MD, MS, and Dawn Hershman, MD, MS, Columbia University, New York, NY; Powel Brown, MD, PhD, MD Anderson Cancer Center, Houston, TX; Gary Goodman, MD, SWOG Chemoprevention Subcommittee and Fred Hutchinson Cancer Research Center, Seattle, WA; Garnet Anderson, PhD, and Danika Lew, MS, SWOG Data Operations and Statistical Center, Seattle, WA; and all participating SWOG members, the Community Clinical Oncology Program (CCOP), and Affiliate Medical Oncologists and Surgeons.
SWOG is one of the five cooperative groups that together comprise the National Cancer Institute’s National Clinical Trials Network. SWOG designs and conducts multidisciplinary clinical trials to improve the practice of medicine in preventing, detecting, and treating cancer, and to enhance the quality of life for cancer survivors. Learn more about SWOG here: http://www.swog.org/Visitors/AboutUs.asp
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