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Current Research Projects

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.

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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.

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Project Title Genomic Analysis of Breast Cancer Risk

Researcher Harry Ostrer, MD, Albert Einstein College of Medicine, Bronx, New York

Study Abstract Genome wide association studies (GWAS) of breast cancer risk have provided clues for the identification of other risk genes. Single nucleotide polymorphisms (SNPs) in or near the FGFR2, TNRC9, MAP3K1, LSP1 and CASP genes, in addition to a presumed regulatory region upstream from the C-MYC gene on chromosome 8q24 and on 2q have been studied in several populations. An alternative approach would be to identify the rare but high-penetrant alleles that are not captured by GWAS. This approach has been successful when applied to studying the tails of the risk distribution for blood pressure and cardiac phenotypes. Recognizing the importance of this approach, the National Heart, Lung and Blood Institute established the Exome Sequencing Project (ESP) to study the tails of the distributions for diseases that fall within their mission. Exome sequencing offers the advantage of surveying key regions of the expressed regions, rather than the entire, genome, thus reducing complexity and cost. The ESP strategy can be applied by analyzing DNA for a well-defined high-risk phenotype (≥3 women affected with premenopausal breast cancer – likely to have a heritable mutation, or early onset breast cancer with no family history – likely to have a de novo mutation) and by studying well-defined populations that are likely to have common founder alleles.

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Project Title Genomics and Breast Cancer Risk in Hispanic Women Study

Researcher Susan Neuhausen, PhD, City of Hope, Duarte, CA

Study Abstract In this proposal, we will focus on breast cancer in Hispanic women. Although Hispanics represent the fastest growing ethnic population in the U.S., they have been largely understudied in terms of genetic susceptibility to cancer even though breast cancer is the most common cancer and causes the most cancer deaths in Hispanic women. The overall long-term goal of this project is the development of a comprehensive clinical genetic test that provides a set of susceptibility genes for inherited breast cancer and can be readily integrated into clinical practice. Specific Aim 1 is to identify variants in 605 genes involved in DNA damage response pathways using next-generation sequencing. We will use DNA from 1000 Latina breast cancer patients and 1000 healthy Latina controls. Specific Aim 2 is to identify the set of variants of biological significance through in silico analyses. Specific Aim 3 is to perform gene-based association tests of the genes and risk to develop breast cancer. We will utilize Hispanic breast cancer cases already participating in Dr. Jeffrey Weitzel’s study. We will recruit Hispanic controls from the Army of Women, focusing on women from California and the Southwest United States. We expect that the results will reveal which genes are important for susceptibility to breast cancer and can be used for possible risk prediction, and provide a number of specific targets for developing therapeutics

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Project Title A Pilot Study of the Flaxseed Effects on Hormones and Lignans: Role of Race, Genes, and Gut Microbiome

Researcher Susan McCann, PhD, Roswell Park Cancer Institute

Study Abstract The objective of this study is to determine how variation in gut microbial
community composition and in steroid hormone and xenobiotic metabolizing genes affects the metabolism of mammalian lignans and steroid hormones at baseline and after exposure to a lignan-rich food (flaxseed), and how these associations differ for African American and Caucasian women. Humans are, in fact, superorganisms with a diverse genetic background that is augmented by diverse and metabolically active bacterial communities, the composition of which can be modified by specific dietary exposures. The central hypothesis is that the metabolic response to a dietary component results from the combined effects of an individual’s genetic makeup and the particular composition of that individual’s gut bacterial communities. Elucidation of interactions between the gut microbiome, host genetics, and diet will have a positive impact on development of improved targeted dietary interventions to reduce cancer risk.

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Project Title Acupuncture for Joint Symptoms in Women with Early Stage Breast Cancer

Researcher Southwest Oncology Group, (SWOG)

Study Abstract The primary objective of this study is to determine whether true acupuncture administered twice weekly for 6 weeks (8-12 sessions) compared to sham acupuncture and waitlist control causes a significant reduction in joint pain/stiffness related to aromatase inhibitors (AIs) in women with early stage breast cancer as measured by the Brief Pain Inventory-Short Form (BPI-SF) worst pain score at 6 weeks.

Secondary objectives are to investigate the effects of true acupuncture administered twice weekly for 6 weeks (8-12 sessions) followed by 6 weekly treatments (4-6 sessions) of maintenance (12-18 sessions total over 12 weeks) compared to sham acupuncture and waitlist control in this study population. The evaluations at 12 and 24 weeks are to determine the benefit of additional 6 weekly acupuncture treatments for maintenance and to determine the durability of response after stopping acupuncture, respectively. The evaluation at 52 weeks is to determine the long-term effects of acupuncture and adherence to AIs.

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Project Title A Study to Identify Predictors of Response to Duloxetine in Breast Cancer Patients with Chronic Pain (HUM00075181)

Researcher Norah Henry, University of Michigan, MD, PhD

Study Abstract The overall goal of this study is to learn more about why some breast cancer survivors develop chronic pain following treatment, in order to better manage their symptoms and improve their quality of life. In this proposal, the research team will investigate if some breast cancer survivors who develop chronic pain have centralized pain, since this could potentially influence treatment recommendations. This question will be addressed in two ways: 1) questionnaires to learn more about the symptoms the patients are experiencing, especially pain, fatigue, sleep disturbances, and memory problems, and 2) pain testing to determine each patient’s pain sensitivity. The research team will then treat the patients on a randomized, blinded clinical trial with duloxetine followed by placebo, or vice versa, in order to identify factors that predict which patients are more likely to benefit from duloxetine therapy. Patients will be assessed before and after each treatment using the methods described above. The hypothesis is that the patients with a greater degree of centralized pain will benefit more from treatment with duloxetine.

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Project Title A Phase II Study of Neratinib in Metastatic HER2 Non-amplified but HER2 Mutant Breast Cancer

Researcher Cynthia Ma, M.D., Ph.D., Washington University, St Louis, MO

Study Abstract The research team proposes to conduct a single arm 2-stage Phase 2 trial of neratinib in metastatic but HER2 non-amplified but HER2 mutant breast cancer. Pre-registration is required for tumor HER2 sequencing. The primary objective is clinical benefit rate (CBR: rate of complete response plus partial response and stable disease > 6 months). With an 80% power and a 1-sided 0.05 significance level, the first stage of 10 patients and the 2nd stage of 19 patients are planned to test an anticipated CBR of 20% versus the null hypothesis of 5%. Secondary endpoints include progression free survival and the molecular epidemiology of HER2 mutation. Exploratory endpoints include mechanisms of treatment resistance and other somatic mutations in HER2 negative disease. Because the mutation frequency is approximately 2%, they anticipate screening of 1500 patients to identify the 29 patients with the HER2 mutation and eligible for study drug therapy. The success of this trial could establish a new treatment option for a subset of patients with HER2 non-amplified tumors.

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Project Title Feasibility Study: Breast Tissue Effects of Hormonal Contraceptive Formulations Study

Researcher Anne Zeleniuch-Jacquotte, MD, MS, and Tess Clendenen, PhD, New York University Medical Center, NY

Study Abstract MRI characteristics, such as the volume and percent of fibroglandular tissue (FGT), the apparent diffusion coefficient (ADC), and background parenchymal enhancement (BPE), have been shown to be hormonally responsive, including during the natural menstrual cycle, by our group and others. MRI FGT and BPE measures were also associated with an increased risk of breast cancer in a small retrospective study. Long-term, this research team would like to evaluate the utility of these MRI measures for examining the effects of different hormonal contraceptive formulations on the breast tissue and infer their potential impact on breast cancer risk. Breast tissue biopsies collected concurrently with MRI can provide information about the effect of OCs on molecular characteristics in the breast tissue that are known to be associated with risk (e.g. breast cell proliferation and expression of genes involved in breast cancer).

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Project Title Multimodal MRI Biomarkers of Mild Cognitive Impairment in Breast Cancer

Researcher Shelli Kesler, PhD, University of Texas MD Anderson Cancer Center, Houston, Texas

Study Abstract The specific aims of the proposed study are therefore to 1) determine the frequency of MCI in older breast cancer subjects who receive chemotherapy, 2) identify DMN neuroimaging biomarkers in older breast cancer subjects treated with chemotherapy, and 3) develop models that predict vulnerability to MCI in this population. We will accomplish these aims by integrating longitudinal measures of cognitive function with advanced, non-invasive magnetic resonance imaging techniques. We will evaluate 55 women with primary breast cancer prior to chemotherapy, one month following chemotherapy and six months after chemotherapy. We will compare the chemotherapy-treated group to 55 women with breast cancer who do not receive chemotherapy and 55 healthy females, all assessed at the same time intervals as the chemotherapy-treated group. We will emphasize the assessment of memory and executive function as well as DMN functional connectivity. We will incorporate treatment, demographic, psychiatric (e.g. depression, fatigue) and genetic (e.g. APOE) factors with DMN connectivity into our predictive models of MCI. Identifying neuroimaging biomarkers underlying chemotherapy-related MCI will improve identification of individuals at highest risk for neurodegeneration and aid the development of treatments for these impairments.

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Project Title Genetics of Chemotherapy-Related Amenorrhea Study

Researcher Kathryn Ruddy, MD MPH, and Celine Vachon, PhD, Mayo Clinic, Rochester, Minnesota

Study Abstract Chemotherapy for breast cancer can damage the ovaries and cause infertility and menopausal symptoms. Learning more about genetic predictors of chemotherapy-related amenorrhea (a surrogate for treatment-related infertility) could help inform decision-making about breast cancer treatments. This study aims to survey breast cancer survivors about how chemotherapy affected their menstrual periods, and to collect saliva samples in which we can look for genetic variants that are associated with a greater risk of early menopause. The research team will also be asking for permission to collect and review medical records to obtain detailed treatment information for these analyses.

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Project Title Avon Viral IL-10 in Cancer Study (AVICS)

Researcher Juliet Spencer, PhD, University of San Francisco, CA

Study Abstract The overall goals of this project are to develop a novel quantitative laboratory test to detect cmvIL-10 in human serum and to evaluate whether cmvIL-10 serum levels correlate with breast cancer. The cmvIL-10 protein is a homolog of human IL-10 that binds the cellular IL-10 receptor and displays many of the same immune-suppressive functions of human IL-10, despite having limited amino acid sequence identity to the cellular cytokine. Elevated levels of IL-10 are frequently detected in the serum of cancer patients and correlate with poor prognosis. In this study, the research team plans to utilize the Army of Women to recruit 300 female volunteers; 150 healthy women and 150 women with varying stages of breast cancer. The volunteers will be asked for a blood sample which will be used to determine HCMV serostatus and to screen for levels of both human IL-10 and cmvIL-10. Volunteers will be recruited only at the University of San Francisco site only.

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Project Title Project Connect Online

Researcher Patricia Ganz, M.D., University of California, Los Angeles.

Study Abstract The research team is conducting a randomized trial that is examining the impact of development of a personalized website to communicate with family and friends—called Project Connect Online (PCO). Women with metastatic breast cancer are randomly assigned to receive the training with a group of other women, or to be trained alone. Women in the group training are encouraged to connect with each other through their websites. Women are assessed pre-intervention, 2 months later and 4 months thereafter.

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Project Title Mapping the Breast Ducts Study

Researcher Susan Love, MD, Dr. Susan Love Research Foundation, Encino, CA

Study Abstract Breast cancer is thought to begin in the lining of the breast ducts with an increase in the lining cells termed intraductal carcinoma in situ or ductal carcinoma in situ (DCIS). Sometimes these cells will necrose and calcify manifesting on a mammogram as microcalfications. Unfortunately, these specs of calcium do not demarcate the extent of the disease. This along with the fact that we don’t know the basic anatomical patterns of the breast ducts means that surgeons are blindly removing tissue in an inefficient effort to remove the pathology, more often than not leading to mastectomy in an attempt to eliminate a disease which is not life threatening nor even cancer by most definitions.

An understanding of the usual distribution of the milk ducts in the breast along with common variations has the potential to put the surgery of the breast on anatomical footing. It would also set the stage for further exploration of non-invasive ways to address the premalignant condition of DCIS through ductoscopy, local therapy, or watchful waiting.

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Project Title Enhancing the Experience of Endocrine Therapy

Researcher Annette Stanton, Ph.D., University of California, Los Angeles, Los Angeles, California

Study Abstract BACKGROUND: Current guidelines recommend at least five years of tamoxifen or aromatase inhibitors after primary treatment for hormone receptor-positive breast cancer. Nonadherence (ie, failing to take the medication as prescribed) and nonpersistence (ie, discontinuing the medication prior to the prescribed duration) with endocrine therapy are common.

OBJECTIVE: The primary goal of this study is to provide a pilot test of brief videos designed to promote adherence to endocrine therapy.

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