| breast cancer clinical study: WHO List of Priority Medical Devices for Cancer Management World Health Organization, 2017-05-09 This is the model list and clearing house of appropriate, basic, and priority medical devices based on the list of clinical interventions selected from clinical guidelines on prevention, screening, diagnosis, treatment, palliative care, monitoring, and end of life care. This publication addresses medical devices that can be used for the management of cancer and specifically describes medical devices for six types of cancer: breast, cervical, colorectal, leukemia, lung, and prostate. This book is intended for ministries of health, public health planners, health technology managers, disease management, researchers, policy makers, funding, and procurement agencies and support and advocacy groups for cancer patients. |
| breast cancer clinical study: Transforming Clinical Research in the United States Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2010-10-22 An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise. |
| breast cancer clinical study: Preoperative (Neoadjuvant) Chemotherapy Joseph Ragaz, Pierre R. Band, James H. Goldie, 2012-12-06 Despite recent advances in adjuvant therapies of cancer, the regi mens of postoperative adjuvant chemotherapy treatment which are presently available fail to cure the majority of cancer patients. Pre operative (neoadjuvant) chemotherapy represents a new approach in drug scheduling, based on sound theoretical, pharmacokinetic, and experimental principles. The preoperative timing of chemotherapy before definitive sur gery is not a minor change in the therapy of cancer. To be successful, large numbers of practitioners and their patients must participate. Substantial alterations of many aspects of the present management of cancer will have to follow. Therefore, before such therapy can be fully and routinely implemented, results of the novel treatment and its rationale have to be carefully evaluated. In preoperative treatment, other features will likely gain impor tance. For the first time, clinicians have a chance to follow the in vivo response of the tumor exposed to preoperative chemotherapy. The subsequent histological assessment of the tumor sample may likely become an important prognostic guide, permitting more re fined individual approaches to the planning of postoperative adju vant treatment. The value of such a treatment strategy can already be appreciated in the clinical setting, as seen from the therapy of osteosarcoma. Furthermore, preoperative chemotherapy might render previously inoperable tumors operable and hence resectable with a curative intention. The preoperative reduction of tumor bulk may also effectively decrease the need for more radical operations, permitting a more uniform adoption of conservative surgery. |
| breast cancer clinical study: Clinical Trials in Oncology, Third Edition Stephanie Green, Jacqueline Benedetti, Angela Smith, John Crowley, 2012-05-09 The third edition of the bestselling Clinical Trials in Oncology provides a concise, nontechnical, and thoroughly up-to-date review of methods and issues related to cancer clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the pitfalls inherent in these processes. In addition, the book has been restructured to have separate chapters and expanded discussions on general clinical trials issues, and issues specific to Phases I, II, and III. New sections cover innovations in Phase I designs, randomized Phase II designs, and overcoming the challenges of array data. Although this book focuses on cancer trials, the same issues and concepts are important in any clinical setting. As always, the authors use clear, lucid prose and a multitude of real-world examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. Armed with Clinical Trials in Oncology, Third Edition, clinicians and statisticians can avoid the many hazards that can jeopardize the success of a trial. |
| breast cancer clinical study: A National Cancer Clinical Trials System for the 21st Century Institute of Medicine, Board on Health Care Services, Committee on Cancer Clinical Trials and the NCI Cooperative Group Program, 2010-07-08 The National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. However, the program is falling short of its potential, and the IOM recommends changes that aim to transform the Cooperative Group Program into a dynamic system that efficiently responds to emerging scientific knowledge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research. |
| breast cancer clinical study: Targeted Therapies in Breast Cancer Gw Sledge, George W. Sledge (Jr.), 2012-06 This new volume updates the reader on selected areas of targeted therapy in breast cancer, with special emphasis on chemoprevention strategies, drug resistance, biomarkers, combination chemotherapy, angiogenesis inhibition and pharmacogenomics in the context of clinical efficacy. This selected review of targeted therapies will guide the reader on effective treatment as part of an integrated programme of patient management. |
| breast cancer clinical study: Assessment of Cancer Screening Pamela M. Marcus, 2022 Cancer screening is a prominent strategy in cancer control in the United States, yet the ability to correctly interpret cancer screening data eludes many researchers, clinicians, and policy makers. This open access primer rectifies that situation by teaching readers, in simple language and with straightforward examples, why and how the population-level cancer burden changes when screening is implemented, and how we assess whether that change is of benefit. This book provides an in-depth look at the many aspects of cancer screening and its assessment, including screening phenomena, performance measures, population-level outcomes, research designs, and other important and timely topics. Concise, accessible, and focused, Assessment of Cancer Screening: A Primer is best suited to those with education or experience in clinical research or public health in the United States - no previous knowledge of cancer screening assessment is necessary. This is the first text dedicated to cancer screening theory and methodology to be published in 20 years. |
| breast cancer clinical study: Percutaneous Breast Biopsy Steve H. Parker, William E. Jobe, 1993 A comprehensive treatment of large-core needle biopsy, a new technique for the early diagnosis of breast cancer. Considers the history of the technique, equipment, the principles of stereotactic mammography, and several procedures using ultrasound. The roles and perspectives of the pathologist, the nurse, and the technologist are delineated, with the emphasis on teamwork. Also evaluates fine-needle aspiration biopsy. Addressed to radiologists. Highly illustrated. Annotation copyright by Book News, Inc., Portland, OR |
| breast cancer clinical study: Landmark Trials in Oncology Santosh Yajnik, 2019-05-17 This book describes the evolution of treatment in oncology through the lens of approximately 250 landmark clinical trials. The well-designed clinical trial is essential to the practice of medicine. There is no field that has embraced or been transformed more by the clinical trial than oncology. Each primary cancer site has a remarkable story that can be told through clinical trials. For example, patients who presented decades ago with soft tissue sarcoma of the extremities would invariably undergo limb amputation. The landmark National Cancer Institute study by Rosenberg et al. randomized patients to limb sparing surgery followed by adjuvant radiation therapy compared with limb amputation. This study helped change the standard of care by allowing most patients to retain their functioning limbs with an improvement in quality of life and no compromise in overall survival. Such major clinical trials for common malignancies including breast, prostate, lung, gastrointestinal, genitourinary, and gynecologic cancers are discussed. Because oncology is multidisciplinary, this book should be of interest for radiation oncologists, surgeons, medical oncologists, and other physicians interested in learning more about the landmark trials that have shaped oncology. |
| breast cancer clinical study: Cancer Incidence and Survival Among Children and Adolescents , 1999 |
| breast cancer clinical study: Keto for Cancer Miriam Kalamian, 2017 A Comprehensive Guide for Patients and Practitioners Although evidence supporting the benefits of ketogenic diet therapies continues to mount, there is little to guide those who wish to adopt this diet as a metabolic therapy for cancer. Keto for Cancer fills this need. Inspired by the work of Dr. Thomas N. Seyfried, PhD, nutritionist Miriam Kalamian has written the first book to lay out comprehensive guidelines that specifically address the many challenges associated with cancer, and particularly the deep nutritional overhaul involved with the ketogenic diet. Kalamian, a leading voice in the keto movement, is driven by passion from her own experience in using the ketogenic diet for her young son. Her book addresses the nuts and bolts of adopting the diet, from deciding whether keto is the right choice to developing a personal plan for smoothly navigating the keto lifestyle. It is invaluable for both beginners and seasoned users of the ketogenic diet, as well as for health-care professionals who need a toolkit to implement this targeted metabolic therapy. The book guides readers to a deeper understanding of the therapeutic potential of the ketogenic diet--which extends well beyond simply starving cancer--emphasizing the powerful impact the diet has on the metabolism of cancer cells. Nutritional nuances are explored in sections such as Fasting Protocols and Know What's in the Foods You Eat while meal templates and tracking tools are provided in Preparing Keto Meals. Kalamian also discusses important issues such as self-advocacy. Readers of Keto for Cancer are empowered to get off the bench and get in the game. To that end, Kalamian offers tips on how to critically examine cancer-care options then incorporate what resonates into a truly personalized treatment plan. |
| breast cancer clinical study: HER2-Positive Breast Cancer Sara Hurvitz, Kelly McCann, 2018-07-26 Get a quick, expert overview of clinically-focused topics and guidelines that are relevant to testing for HER2, which contributes to approximately 25% of breast cancers today. This concise resource by Drs. Sara Hurvitz, and Kelly McCann consolidates today's available information on this growing topic into one convenient resource, making it an ideal, easy-to-digest reference for practicing and trainee oncologists. - Covers the diagnosis, treatments and targeted therapies, and management of breast cancers that are HER2-positive. - Contains sections on background and testing, advanced disease, therapeutics, and toxicity considerations. - Includes a timely section on innovative future therapies. |
| breast cancer clinical study: Breast Cancer Metastasis and Drug Resistance Aamir Ahmad, 2019-08-27 Resistance to therapies, both targeted and systemic, and metastases to distant organs are the underlying causes of breast cancer-associated mortality. The second edition of Breast Cancer Metastasis and Drug Resistance brings together some of the leading experts to comprehensively understand breast cancer: the factors that make it lethal, and current research and clinical progress. This volume covers the following core topics: basic understanding of breast cancer (statistics, epidemiology, racial disparity and heterogeneity), metastasis and drug resistance (bone metastasis, trastuzumab resistance, tamoxifen resistance and novel therapeutic targets, including non-coding RNAs, inflammatory cytokines, cancer stem cells, ubiquitin ligases, tumor microenvironment and signaling pathways such as TRAIL, JAK-STAT and mTOR) and recent developments in the field (epigenetic regulation, microRNAs-mediated regulation, novel therapies and the clinically relevant 3D models). Experts also discuss the advances in laboratory research along with their translational and clinical implications with an overarching goal to improve the diagnosis and prognosis, particularly that of breast cancer patients with advanced disease. |
| breast cancer clinical study: Cancer Clinical Trials Hans Scheurlen, Richard Kay, Michael Baum, 2012-12-06 The controlled clinical trial has become an essential part of the clinician's decision-making process. Clinical trials, however, still raise methodological problems that are important and at the same time controversial: subgroup analysis and interactions, meta-analy sis of similar trials, consideration of subjective clinical opinions and those of the public at large, assessment of quality of life, pre vention trials, and so on. In February 1987 we took our third step along the road to evaluating these issues in dialogues between cli nicians, psychologists, legal experts, and statisticians. The talks presented at the meeting were revised by the authors afterwards and have been rearranged by the editors to form a strictly organ 1 2 ized book. The two preceding meetings in 1978 and 1981 focused strongly on adjuvant therapy in primary breast cancer, but this top ic served merely as a nucleus in the third meeting. This meeting, although called the Third Heidelberg Symposium was forced to leave Heidelberg and in fact was held in Freiburg. Without the interest and enthusiasm of Professor Martin Schu macher and his colleagues in Freiburg the meeting would never have taken place. The meeting was generously supported again by the Federal Ministry of Research and Technology (Bundesministe rium flir Forschung und Technologie, BMFT) within the framework of the West German BMFT Breast Cancer Study Group. We are grateful, in particular, to Mr. Hans W. Herzog for his personal in volvement. Juni 1988 H. Scheurlen, R. Kay, M. |
| breast cancer clinical study: A Series of Catastrophes and Miracles Mary Elizabeth Williams, 2016-04-26 A wry, witty account of what it is like to face death—and be restored to life. After being diagnosed in her early 40s with metastatic melanoma—a rapidly fatal form of cancer—journalist and mother of two Mary Elizabeth Williams finds herself in a race against the clock. She takes a once-in-a-lifetime chance and joins a clinical trial for immunotherapy, a revolutionary drug regimen that trains the body to vanquish malignant cells. Astonishingly, her cancer disappears entirely in just a few weeks. But at the same time, her best friend embarks on a cancer journey of her own—with very different results. Williams's experiences as a patient and a medical test subject reveal with stark honesty what it takes to weather disease, the extraordinary new developments that are rewriting the rules of science—and the healing power of human connection. |
| breast cancer clinical study: Accelerated Partial Breast Irradiation David E. Wazer, Douglas W. Arthur, Frank Vicini, 2009-08-11 Accelerated partial breast irradiation (APBI) is being rapidly introduced into the clinical management of early breast cancer. APBI, in fact, encompasses a number of different techniques and approaches that include brachytherapy, intraoperative, and external beam techniques. There is currently no single source that describes these techniques and their clinical implementation. This text is a concise handbook designed to assist the clinician in the implementation of APBI. This includes a review of the principles that underlie APBI, a practical and detailed description of each technique for APBI, a review of current clinical results of APBI, and a review of the incidence and management of treatment related complications. |
| breast cancer clinical study: Clinical Trials in Oncology Stephanie Green, Jacqueline Benedetti, 2012-05-09 The new edition of the bestselling Clinical Trials in Oncology provides a concise, nontechnical, and now thoroughly up-to-date review of methods and issues related to clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the pitfalls inherent in these processes. This edition includes a new section covering innovations in Phase I designs and another on overcoming the challenges of array data. As always, the authors use clear, lucid prose and a multitude of real-world trials as examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. |
| breast cancer clinical study: Clinical Trials in Oncology Stephanie Green, John Crowley, Angela Smith, 2010-12-12 Studies that are unimpeachably thorough, non-political, unbiased, and properly designed These are the standards to which everyone in clinical research aspires. Yet, the difficulties in designing trials and interpreting data are subtle and ever present. The new edition of Clinical Trials in Oncology provides a concise, nontechnical, and now |
| breast cancer clinical study: Breast Cancer in Young Women Oreste Gentilini, Ann H. Partridge, Olivia Pagani, 2020-02-07 This contributed book covers all aspects concerning the clinical scenario of breast cancer in young women, providing physicians with the latest information on the topic. Young women are a special subset of patients whose care requires dedicated expertise. The book, written and edited by internationally recognized experts who have been directly involved in the international consensus guidelines for breast cancer in young women, pays particular attention to how the disease and its planned treatment can be effectively communicated to young patients. Highly informative and carefully structured, it provides both theoretical and practice-oriented insight for practitioners and professionals involved in the different phases of treatment, from diagnosis to intervention, to follow-up – without neglecting the important role played by prevention. |
| breast cancer clinical study: Periodic Screening for Breast Cancer Sam Shapiro, 1988 Presents a full account of the HIP project's background, methodology, and final result. On determining whether periodic breast cancer screening with mammography and clinical examination of the breast holds substantial promise for lowering mortality in the female population from breast cancer. Annotation copyright Book News, Inc. Portland, Or. |
| breast cancer clinical study: Her-2 Robert Bazell, 2011-04-27 Two years after she underwent a mastectomy and chemotherapy, Barbara Bradfield's aggressive breast cancer had recurred and spread to her lungs. The outlook was grim. Then she took part in Genentech's clinical trials for a new drug. Five years later she remains cancer-free. Her-2 is the biography of Herceptin, the drug that provoked dramatic responses in Barbara Bradfield and other women in the trials and that offers promise for hundreds of thousands of breast cancer patients. Unlike chemotherapy or radiation, Herceptin has no disabling side effects. It works by inactivating Her-2/neu--a protein that makes cancer cells grow especially quickly-- produced by a gene found in 25 to 30 percent of all breast tumors. Herceptin caused some patients' cancers to disappear completely; in others, it slowed the progression of the disease and gave the women months or years they wouldn't otherwise have had. Herceptin is the first treatment targeted at a gene defect that gives rise to cancer. It marks the beginning of a new era of treatment for all kinds of cancers. Robert Bazell presents a riveting account of how Herceptin was born. Her-2 is a story of dramatic discoveries and strong personalities, showing the combination of scientific investigation, money, politics, ego, corporate decisions, patient activism, and luck involved in moving this groundbreaking drug from the lab to a patient's bedside. Bazell's deft portraits introduce us to the remarkable people instrumental in Herceptin's history, including Dr. Dennis Slamon, the driven UCLA oncologist who played the primary role in developing the treatment; Lily Tartikoff, wife of television executive Brandon Tartikoff, who tapped into Hollywood money and glamour to help fund Slamon's research; and Marti Nelson, who inspired the activists who lobbied for a compassionate use program that would allow women outside the clinical trials to have access to the limited supplies of Herceptin prior to FDA approval of the drug. And throughout there are the stories of the heroic women with advanced breast cancer who volunteered for the trials, risking what time they had left on an unproven treatment. Meticulously researched, written with clarity and compassion, Her-2 is masterly reporting on cutting-edge science. |
| breast cancer clinical study: Advances in Breast Cancer Management, 2nd edition William J. Gradishar, William C. Wood, 2000-08-31 The optimal management of breast cancer patients relies on the expertise of a team of medical specialists including radiologists, surgeons, radiation therapists and medical oncologists. Much of the progress in breast cancer management made over the last several years reflects the translation of observations made in the laboratory to the clinic. Critically evaluating the impact of new treatment approaches relies on a commitment to well-designed clinical trials. In this volume, Advances in Breast Cancer Management, a renowned group of breast cancer experts have been asked to provide their perspective on management issues that directly effect patients on a day-to-day basis. Dr. Melody Cobleigh discusses the consequences of estrogen deprivation and the ways of ameliorating secondary symptoms and the potential long-term morbidity. Drs. Haigh and Guiliano review the sentinel lymph node biopsy technique including results from their extensive experience. Dr. Abram Recht places into perspective the potential benefit of post-mastectomy radiotherapy and reviews recent trials that address this issue. Dr. Dennis Slamon takes from us from the laboratory to the clinic in explaining the development of Herceptin as a paradigm for therapy targeted to specific molecular characteristics of breast cancer tumor cells. Drs. Nieto, Shpall, Crump and Pritchard offer different perspectives on the future of high-dose chemotherapy with stem cell transplantation as a treatment for breast cancer patients. Drs. |
| breast cancer clinical study: Cancer and Aging M. Extermann, 2013-01-18 Cancer is clearly an age-related disease. Recent research in both aging and cancer has demonstrated the complex interaction between the two phenomena. This affects a wide spectrum of research and practice, anywhere from basic research to health care organization. Core examples of these close associations are addressed in this book. Starting with basic research, the first chapters cover cancer development, mTOR inhibition, senescent cells altering the tumor microenvironment, and immune senescence affecting cancer vaccine response. Taking into account the multidisciplinarity of geriatric oncology, several chapters focus on geriatric and oncologic aspects in patient assessment, treatment options, nursing and exercise programs. The book is rounded off by a discussion on the impact of the metabolic syndrome illustrating the interactions between comorbidity and cancer and a chapter on frailty.This book provides the reader with insights that will hopefully foster his or her reflection in their own research and practice to further the development of this most exciting field. Given the aging of the population worldwide and the high prevalence of cancer, it is essential reading not only for oncologists and geriatricians but for all health practitioners. |
| breast cancer clinical study: Hepatobiliary Cancer Yuman Fong, Jia-Hong Dong, 2014 Hepatobiliary Cancer addresses the field with contributions from talented practitioners from around the world in surgery, chemotherapy, radiation therapy, medical oncology, and integrative medicine. The text approaches these cancers by type – biliary and liver tumors – and in terms of diagnostic techniques and therapies: surgical, ablative, systemic and regional chemotherapies, biologic, and complementary. Hepatobiliary Cancer is essential reading for anyone expert in, or engaged in learning about, treating hepatobiliary cancers. Heavily illustrated with photomicrographs, photographs, drawings, and tables to support and illuminate the text, it is a concise, yet comprehensive guide to hepatobiliary cancer diagnosis and treatment. |
| breast cancer clinical study: Bad Pharma Ben Goldacre, 2014-04 Originally published in 2012, revised edition published in 2013, by Fourth Estate, Great Britain; Published in the United States in 2012, revised edition also, by Faber and Faber, Inc. |
| breast cancer clinical study: Biomarkers in Breast Cancer Giampietro Gasparini, Daniel F. Hayes, 2008-01-17 Expert laboratory and clinical researchers from around the world review how to design and evaluate studies of tumor markers and examine their use in breast cancer patients. The authors cover both the major advances in sophisticated molecular methods and the state-of-the-art in conventional prognostic and predictive indicators. Among the topics discussed are the relevance of rigorous study design and guidelines for the validation studies of new biomarkers, gene expression profiling by tissue microarrays, adjuvant systemic therapy, and the use of estrogen, progesterone, and epidermal growth factor receptors as both prognostic and predictive indicators. Highlights include the evaluation of HER2 and EGFR family members, of p53, and of UPA/PAI-1; the detection of rare cells in blood and marrow; and the detection and analysis of soluble, circulating markers. |
| breast cancer clinical study: Early Diagnosis and Treatment of Cancer Series: Breast Cancer - E-Book Lisa Jacobs, Christina Finlayson, 2010-07-15 Each volume in the Early Detection and Treatment of Cancer Series is packed with practical, authoritative information designed to cover the full range of diagnostic procedures, including pathologic, radiologic, bronchoscopic, and surgical aspects. You’ll be able to determine the safest, shortest, least invasive way to reach an accurate diagnosis; stage the disease; and choose the best initial treatment for early stages. Based on current evidence in the literature, authors provide clinical, hands-on tools to help you make informed decisions on precisely what tests and imaging studies are needed to diagnose and stage each type of cancer. Practical, authoritative, and highly-illustrated, this volume in the brand new Early Detection and Treatment of Cancer series covers current protocols and the latest advances in diagnostic imaging and molecular and serologic markers for breast cancer. Apply expert advice on the best “next-step plan for different presentations and tips for less invasive protocols. Get clinical, hands-on tools to help you make informed decisions on precisely what tests and imaging studies are needed for accurate diagnosis and staging. Clear figures, tables, and boxes illustrate step-by-step care of the full range of problems encountered. The small size and convenient format make this an ideal purchase for diagnostic reference. Outlines the steps after diagnosis to guide you through formulating a treatment or patient care plan. Emphasizes important points—such as the promising new breast cancer vaccine, sentinel node biopsy, and hormone receptor tests—with “key points boxes at the beginning of each chapter and pedagogic features throughout. Summarizes the process of accurately diagnosing and staging cancer in a logical, almost algorithmic, approach for easy reference. Discusses the treatment of early-stage disease so you have clear options for care. Complements the procedures outlined in the text with full-color photographs and line drawings to reinforce your understanding of the material. |
| breast cancer clinical study: Challenges for the FDA Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2007-10-02 As the principal agency regulating food, drugs, medical devices, and biological products used by Americans, the U.S. Food and Drug Administration (FDA) serves one of the most critical consumer protection functions of the federal government. The FDA's reach is enormous, regulating products that represent roughly 25 percent of all consumer spending in the United States. Since 1992, however, federal funding for the agency has diminished, and the FDA's Center for Drug Evaluation and Research (CDER) currently relies on the fees it receives from the industry it regulates to fund the majority of its drug regulation functions. Prescription drug safety is receiving heightened press coverage and congressional scrutiny as a result of recent, highly publicized events, such as the recall of Vioxx because of its link to heart attacks, and the link between certain antidepressants (selective serotonin reuptake inhibitors, or SSRIs) and an increased risk of suicidal ideation in children. To address these concerns, the FDA in 2005 commissioned the Institute of Medicine (IOM) to conduct an independent assessment of the current U.S. drug safety system. In September 2006, the IOM committee released its report-The Future of Drug Safety: Promoting and Protecting the Health of the Public-which included 25 recommendations for improving the system for drug safety review. The committee identified four major vulnerabilities in the U.S. drug safety system: (1) chronic underfunding; (2) organization problems, particularly inadequate integration of pre-and postmarket data review; (3) a range of technical problems related to the insufficient quantity and quality of postmarket data and inadequate capability to systematically monitor the risks and benefits of drugs after marketing; and (4) unclear regulatory authority and insufficiently flexible regulatory tools. Since the IOM report was issued, the FDA has taken a number of steps toward implementing the recommended improvements. Like many government agencies, however, the FDA is financially strained by its existing responsibilities, and fully implementing the recommended improvements to the drug safety system would require significant financial commitments.The IOM report addressed some of the costs associated with its recommendations, but left many unanswered questions about the resources required to fully achieve the envisioned improvements. To better understand the types and magnitude of resources required to achieve the goals of the IOM report, the IOM's Forum on Drug Discovery, Development, and Translation convened a 1-day symposium in March 2007. Challenges for the FDA: The Future of Drug Safety, Workshop Summary explains the presentations and discussions in seven key areas: addressing the FDA's resource challenges; strengthening the scientific base of the agency; integrating pre- and postmarket review; enhancing postmarket safety monitoring; conducting confirmatory drug safety and efficacy studies; enhancing the value of clinical trial registration; and enhancing the FDA's postmarket regulation and enforcement. |
| breast cancer clinical study: Clinical Trials in "early" breast cancer , 1979 |
| breast cancer clinical study: Diagnosing and Treating Adult Cancers and Associated Impairments National Academies Of Sciences Engineeri, National Academies of Sciences Engineering and Medicine, Health And Medicine Division, Board On Health Care Services, Committee on Diagnosing and Treating Adult Cancers, 2021-11-10 Cancer is the second leading cause of death among adults in the United States after heart disease. However, improvements in cancer treatment and earlier detection are leading to growing numbers of cancer survivors. As the number of cancer survivors grows, there is increased interest in how cancer and its treatments may affect a person's ability to work, whether the person has maintained employment throughout the treatment or is returning to work at a previous, current, or new place of employment. Cancer-related impairments and resulting functional limitations may or may not lead to disability as defined by the U.S. Social Security Administration (SSA), however, adults surviving cancer who are unable to work because of cancer-related impairments and functional limitations may apply for disability benefits from SSA. At the request of SSA, Diagnosing and Treating Adult Cancers and Associated Impairments provides background information on breast cancer, lung cancer, and selected other cancers to assist SSA in its review of the listing of impairments for disability assessments. This report addresses several specific topics, including determining the latest standards of care as well as new technologies for understanding disease processes, treatment modalities, and the effect of cancer on a person's health and functioning, in order to inform SSA's evaluation of disability claims for adults with cancer. |
| breast cancer clinical study: Early Detection of Breast Cancer S. Brünner, B. Langfeldt, P. E. Andersen, 2012-12-06 The enormous expansion seen over the last decade in the mammo graphic detection of breast cancer lesions, especially the use of screen ing procedures for the early detection of clinically unsuspected tumors, has made it necessary to summarize the experience made by various centers in the world. The 2nd International Copenhagen Symposium on Detection of Breast Cancer afforded an opportunity of gathering scientists from all over the world to discuss the various problems of early breast cancer detection with special reference to screening procedures. This book forms a synthesis of the information presented by leading scientists from many of the world's mammo graphic centers, particularly those in Sweden and the USA. Hence, the reader will have the opportunity to study the outstanding work carried out by various institutes and centers of breast cancer screening. It is our sincere hope that a study of this volume will encourage other scientists to join in the work on screening procedures. S. Brunner B. Langfeldt P. E. Andersen Contents S. A. Feig: 1 Hypothetical Breast Cancer Risk from Mammography S. A. Feig: Benefits and Risks of Mammography 11 R. L. Egan and M. B. McSweeney: Multicentric Breast Carcinoma . . . . . . . . . . . . . . . . . . . . . . . . 28 M. B. McSweeney and R. L. Egan: Breast Cancer in the Younger Patient: A Preliminary Report 36 M. B. McSweeney and R. L. Egan: Bilateral Breast Carcinoma . . . . . . . . . . . . . . . . . . . . . . . . . . . ' 41 N. Bjurstam: The Radiographic Appearance of Normal and Metastatic Axillary Lymph Nodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 M. Moskowitz, S. A. Feig, C. Cole-Beuglet, S. H. |
| breast cancer clinical study: Community Clinical Oncology Program (COOP) Alice Collins Hamm, 1985 |
| breast cancer clinical study: Group Therapy For Cancer Patients: A Research-based Handbook Of Psychosocial Care David Spiegel, Catherine Classen, 2008-08-01 This extraordinary resource celebrates and expands on Dr. David Spiegel's discovery that a shared intimacy with mortality creates very different concerns in the patient from those that apply in conventional settings. Spiegel and Classen introduce mental health professionals to the awareness as well as the tools they will need to facilitate groups coping with existential crises. The result is a model for helping that actually helps. |
| breast cancer clinical study: Translational Research in Breast Cancer Dong-Young Noh, Wonshik Han, Masakazu Toi, 2021-05-13 This book describes recent advances in translational research in breast cancer and presents emerging applications of this research that promise to have meaningful impacts on diagnosis and treatment. It introduces ideas and materials derived from the clinic that have been brought to the bench for basic research, as well as findings that have been applied back to the bedside. Detailed attention is devoted to breast cancer biology and cell signaling pathways and to cancer stem cell and tumor heterogeneity in breast cancer. Various patient-derived research models are discussed, and a further focus is the role of biomarkers in precision medicine for breast cancer patients. Next-generation clinical research receives detailed attention, addressing the increasingly important role of big data in breast cancer research and a wide range of other emerging developments. An entire section is also devoted to the management of women with high-risk breast cancer. Translational Research in Breast Cancer will help clinicians and scientists to optimize their collaboration in order to achieve the common goal of conquering breast cancer. |
| breast cancer clinical study: Adjuvant Therapy for Breast Cancer Monica Castiglione, Martine J. Piccart, 2009-07-11 Adjuvant treatment is administered prior to or as follow up to surgical procedures for breast cancer. Proven success in using medical therapies allowing for breast conserving procedures or reducing risk of occurrence. Although there has been much progress towards a cure, including the introduction of new targeted therapies, metastasizing cancer remains highly incurable. |
| breast cancer clinical study: Subjected to Science Susan E. Lederer, 1997-11-07 Susan Lederer provides the first full-length history of early biomedical research with human subjects. Lederer offers detailed accounts of experiments conducted on both healthy and unhealthy men, women, and children, during the period from 1890 to 1940, including yellow fever experiments, Udo Wile's dental drill experiments on insane patients, and Hideyo Noguchi's syphilis experiments. |
| breast cancer clinical study: Women's Cancers Alison Keen, Elaine Lennan, 2011-04-25 Patients with breast and gynaecological cancers have to contend with a large number of difficult and challenging issues. To help them to do this it is vital that their health carers are fully informed in all aspects of women's cancers. This book provides a comprehensive and meaningful picture of this oncological area, including epidemiology, histopathology, staging, genetic predisposition, sexual function, fertility, treatment and management, survivorship, and palliative care. To give this book added credibility and holistic application, contributions of women with cancer have been included, and the text is interspersed with patient accounts and experiences. Women's Cancers is essential reading for all nurses and health care professionals working in cancer care settings, as well as patients and families. |
| breast cancer clinical study: Cancer Clinical Trials: Proactive Strategies Stanley P. L. Leong, 2007-11-25 Clinical trials remain the most important vehicle for improving the care of cancer patients. This text presents the fundamental components and challenges involving clinical investigations. Leading experts discuss the critical issues covering the spectrum of important topics from planning to application. The book has a foreword by Samuel A. Wells, Jr., MD, Professor of Surgery, Duke University Medical Center, Durham, NC, former Director of the American College of Surgeons and Founder of the American College of Surgeons Oncology Group. |
| breast cancer clinical study: Not the Last Goodbye David Servan-Schreiber, 2011-11-18 This is the story of an award-winning psychiatrist and neuroscientist who was diagnosed with a brain tumour by his own MRI machine at the age of thirty. It is the story of a doctor turned patient who, after overcoming cancer against the odds, started a twenty-year crusade to inform people about the disease and inspire them to take responsibility for their health. It is the story of a husband and father who is told that the cancer has returned, and that he only has a short time left. This is a story about dying. But most of all, it is a story about living. 'A staggering manual for living' Paris Match 'Each word rings true, each memory lingers, each detail of his life, now in limbo, brings us closer to the human condition. This book is a gift' Elle |
| breast cancer clinical study: Clinical Trials in ‘Early’ Breast Cancer H. R. Scheurlen, G. Weckesser, I. Armbruster, 2012-12-06 |
Breast - Wikipedia
Breasts have been featured in ancient and modern sculpture, art, and photography. Breasts can represent fertility, femininity, or abundance. They can figure prominently in the perception of a …
The 12 Different Breast Shapes and Types - Healthline
Apr 26, 2019 · The archetypal breast, which is round and full, with a point at the nipple, may be the most common. But many people with breasts have other shapes, including bell shape and …
Breast Anatomy: Milk Ducts, Tissue, Conditions & Physiology
The breast anatomy of males and females is slightly different. Female breasts have milk ducts and glandular tissue that aid breastfeeding. Male and female breast nipples have many nerves that …
Breast cancer - Symptoms and causes - Mayo Clinic
Each breast contains 15 to 20 lobes of glandular tissue, arranged like the petals of a daisy. The lobes are further divided into smaller lobules that produce milk for breastfeeding. Small tubes, …
Breasts: Anatomy, Types, and Conditions - WebMD
Jun 5, 2024 · Most changes aren't signs of breast cancer or other serious health problems, but some do warrant a check with your doctor. Here’s what to know about breast issues that you …
Anatomy - SEER Training
Jan 10, 2025 · Anatomy of the Female Breast. The breast is made up of lobes and ducts. Each breast has 15 to 20 sections called lobes, which are arranged in a circularfashion. The fat …
The Breasts - Structure - Vasculature - TeachMeAnatomy
Feb 7, 2022 · The breast can be considered to be composed of two regions: Circular body – largest and most prominent part of the breast. Axillary tail – smaller part, runs along the inferior …
Breast Anatomy: Physiology, Labeled, Diagram, Development, …
Feb 20, 2024 · Read about breast anatomy physiology, diagrams, development, lumps, and breast anatomy during pregnancy. See a breast anatomy diagram and learn about the …
Breast Anatomy - National Breast Cancer Foundation
Apr 30, 2025 · A healthy female breast is made up of 12–20 sections called lobes. Each of these lobes is made up of many smaller lobules, the gland that produces milk in nursing women. …
Anatomy of the Breasts - Johns Hopkins Medicine
Each breast has 15 to 20 sections, called lobes. They are arranged like the petals of a daisy. Each lobe has many smaller structures called lobules. These end in dozens of tiny bulbs that can …
Breast - Wikipedia
Breasts have been featured in ancient and modern sculpture, art, and photography. Breasts can represent fertility, femininity, or abundance. They can figure prominently in the perception of a …
The 12 Different Breast Shapes and Types - Healthline
Apr 26, 2019 · The archetypal breast, which is round and full, with a point at the nipple, may be the most common. But many people with breasts have other shapes, including bell shape and …
Breast Anatomy: Milk Ducts, Tissue, Conditions & Physiology
The breast anatomy of males and females is slightly different. Female breasts have milk ducts and glandular tissue that aid breastfeeding. Male and female breast nipples have many nerves that …
Breast cancer - Symptoms and causes - Mayo Clinic
Each breast contains 15 to 20 lobes of glandular tissue, arranged like the petals of a daisy. The lobes are further divided into smaller lobules that produce milk for breastfeeding. Small tubes, …
Breasts: Anatomy, Types, and Conditions - WebMD
Jun 5, 2024 · Most changes aren't signs of breast cancer or other serious health problems, but some do warrant a check with your doctor. Here’s what to know about breast issues that you …
Anatomy - SEER Training
Jan 10, 2025 · Anatomy of the Female Breast. The breast is made up of lobes and ducts. Each breast has 15 to 20 sections called lobes, which are arranged in a circularfashion. The fat …
The Breasts - Structure - Vasculature - TeachMeAnatomy
Feb 7, 2022 · The breast can be considered to be composed of two regions: Circular body – largest and most prominent part of the breast. Axillary tail – smaller part, runs along the inferior …
Breast Anatomy: Physiology, Labeled, Diagram, Development, …
Feb 20, 2024 · Read about breast anatomy physiology, diagrams, development, lumps, and breast anatomy during pregnancy. See a breast anatomy diagram and learn about the different …
Breast Anatomy - National Breast Cancer Foundation
Apr 30, 2025 · A healthy female breast is made up of 12–20 sections called lobes. Each of these lobes is made up of many smaller lobules, the gland that produces milk in nursing women. …
Anatomy of the Breasts - Johns Hopkins Medicine
Each breast has 15 to 20 sections, called lobes. They are arranged like the petals of a daisy. Each lobe has many smaller structures called lobules. These end in dozens of tiny bulbs that can …
