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Applying Real-World Evidence to Improve Clinical Decision-Making for Patients with HR-positive/HER2-negative Metastatic Breast Cancer

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0.25 credits
15 Minutes
Applying Real-World Evidence to Improve Clinical Decision-Making for Patients with HR-positive/HER2-negative Metastatic Breast Cancer
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  • Overview

    Skepticism regarding the use of real-world evidence continues to exist among oncologists, but in actuality, real-world studies can provide information that may aid clinicians in Europe who are treating patients with HR-positive/HER2-negative metastatic breast cancer, especially regarding the use of CDK 4/6 inhibitors.

    This discussion focuses on the fundamental value that real-world evidence can provide in support of randomized clinical trials and how oncologists can best incorporate these data into current clinical practice.  

  • Disclosure of Conflicts of Interest

    In accordance with the ACCME Standards for Commercial Support, Global Learning Collaborative (GLC) requires that individuals in a position to control the content of an educational activity disclose all relevant financial relationships with any commercial interest. GLC resolves all conflicts of interest to ensure independence, objectivity, balance, and scientific rigor in all its educational programs.

    Host:
    Javier Cortes, MD, PhD
    Head, Breast Cancer Program
    IOB Institute of Oncology
    Madrid & Barcelona
    Spain

    Consulting Fees: Astrazeneca, Athenex, Bioasis, Biothera, Boehringer, Celgene, Clovis, Daiichy Sankyo, Erytech, GSK, Leuko, Lilly, Merck, Merus, Polyphor, Roche, Seattle Genetics, Servier
    Contracted Research: Research funding to the Institution: Ariad Pharmaceuticals, AstraZeneca, Baxalta GMBH/Servier Affaires, Bayer Healthcare, Eisai, F.Hoffman-La Roche, Guardanth Health, Merck Sharp&Dohme, Pfizer, Piqur Therapeutics, Puma C, Queen Mary University of London, Roche
    Ownership Interest: MedSIR
    Honoraria: Celgene, Daiichi Sankyo, Eisai, Lilly, Merck Sharp&Dohme, Novartis, Pfizer, Samsung Bioepis, Roche

    Faculty:
    Giuseppe Curigliano, MD, PhD
    Clinical Director
    Division of Early Drug Development for Innovative Therapy
    Co-Chair Cancer Experimental Therapeutics Program
    Department of Oncology and Hemato-Oncology
    University of Milan
    European Institute of Oncology
    Milan, Italy 

    Consulting Fees: Astra Zeneca, Daichii Sankyo, Ellipsis, Lilly, Merck, Novartis
    Commercial Interest Speakers Bureau: Novartis, Pfizer, Roche 

    Peter Schmid, FRCP, MD, PhD
    Centre Lead, Barts Cancer Institute 
    Queen Mary University of London
    London, England

    Consulting Fees: AstraZeneca, Bayer, Boehringer Ingelheim, Celgene, Eisai, Merck, Novartis, Pfizer, Puma, Roche
    Contracted Research: Genentech, Novartis, Oncogenex, Roche
    Other (Spouse Consultancy): Genentech, Roche

    Reviewers/Content Planners/Authors:

    • Jorge Bacigalupo has nothing to disclose.
    • Ann Early has nothing to disclose.
    • Barry A. Fiedel, PhD has nothing to disclose.
    • Amanda Hilferty has nothing to disclose.
    • Brian P. McDonough, MD, FAAFP has nothing to disclose.
  • Learning Objectives

    After participating in this educational activity, participants should be better able to:

    • Discuss the changing landscape that CDK 4/6 inhibitors bring to treatment of HR-positive/HER2-negative metastatic breast cancer.
    • Compare characteristics of data deriving from randomized, controlled clinical trials and those from real-world studies.  
    • Formulate strategies to incorporate real-world studies involving the use of CDK 4/6 inhibitors in broad populations of patients with HR-positive/HER2-negative metastatic breast cancer.
  • Target Audience

    This activity is designed to meet the educational needs of oncologists and other healthcare professionals involved in the care of patients with metastatic breast cancer in Europe.

  • Accreditation and Credit Designation Statements

    Global Learning Collaborative is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

    Global Learning Collaborative designates this enduring material for a maximum of .25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

  • Provider(s)/Educational Partner(s)

    AGILE - Academy for Interprofessional Learning and Education - designs, develops, and delivers education across a broad spectrum of diseases and clinical conditions. Our mission is to serve as a trusted source of clinical information that helps healthcare professionals improve competence, performance, and patient outcomes.

    This activity was codeveloped with La Fundación ECO para la Excelencia y Calidad en la Oncología (The ECO Foundation). The ECO Foundation is a nonprofit medical professional organization in Spain, founded by the majority of the oncology and hematology department heads of the leading cancer centers in Spain with a mission of guaranteeing excellence in cancer care by joining the efforts of leading experts in the field of oncology and hematology.

  • Commercial Support

    This activity is supported by an independent educational grant from Pfizer Inc.

  • Disclaimer

    The views and opinions expressed in this educational activity are those of the faculty and do not necessarily represent the views of GLC and AGILE. This presentation is not intended to define an exclusive course of patient management; the participant should use his/her clinical judgment, knowledge, experience, and diagnostic skills in applying or adopting for professional use any of the information provided herein. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patients’ conditions and possible contraindications or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities. Links to other sites may be provided as additional sources of information. Once you elect to link to a site outside of AGILE, you are subject to the terms and conditions of use, including copyright and licensing restriction, of that site.

    Reproduction Prohibited
    Reproduction of this material is not permitted without written permission from the copyright owner.

    Disclaimer: Some products discussed in this activity may not have received regulatory approval by the US FDA for the treatment of patients. The FDA has stated that “good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement.”

  • System Requirements

    Our site requires a computer, tablet or mobile device and a connection to the Internet. For best results, a high-speed Internet connection is recommended (DSL/cable). We also recommend using the latest version of your favorite browser to ensure compliance with W3C standards, such as Internet Explorer, Microsoft Edge, Chrome, Firefox or Safari. Users accustomed to IE8, IE9 IE10 are advised to update their browsers for the best experience.

  • Publication Dates

    Release Date:

    Expiration Date:

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Details
Presenters
Comments
  • Overview

    Skepticism regarding the use of real-world evidence continues to exist among oncologists, but in actuality, real-world studies can provide information that may aid clinicians in Europe who are treating patients with HR-positive/HER2-negative metastatic breast cancer, especially regarding the use of CDK 4/6 inhibitors.

    This discussion focuses on the fundamental value that real-world evidence can provide in support of randomized clinical trials and how oncologists can best incorporate these data into current clinical practice.  

  • Disclosure of Conflicts of Interest

    In accordance with the ACCME Standards for Commercial Support, Global Learning Collaborative (GLC) requires that individuals in a position to control the content of an educational activity disclose all relevant financial relationships with any commercial interest. GLC resolves all conflicts of interest to ensure independence, objectivity, balance, and scientific rigor in all its educational programs.

    Host:
    Javier Cortes, MD, PhD
    Head, Breast Cancer Program
    IOB Institute of Oncology
    Madrid & Barcelona
    Spain

    Consulting Fees: Astrazeneca, Athenex, Bioasis, Biothera, Boehringer, Celgene, Clovis, Daiichy Sankyo, Erytech, GSK, Leuko, Lilly, Merck, Merus, Polyphor, Roche, Seattle Genetics, Servier
    Contracted Research: Research funding to the Institution: Ariad Pharmaceuticals, AstraZeneca, Baxalta GMBH/Servier Affaires, Bayer Healthcare, Eisai, F.Hoffman-La Roche, Guardanth Health, Merck Sharp&Dohme, Pfizer, Piqur Therapeutics, Puma C, Queen Mary University of London, Roche
    Ownership Interest: MedSIR
    Honoraria: Celgene, Daiichi Sankyo, Eisai, Lilly, Merck Sharp&Dohme, Novartis, Pfizer, Samsung Bioepis, Roche

    Faculty:
    Giuseppe Curigliano, MD, PhD
    Clinical Director
    Division of Early Drug Development for Innovative Therapy
    Co-Chair Cancer Experimental Therapeutics Program
    Department of Oncology and Hemato-Oncology
    University of Milan
    European Institute of Oncology
    Milan, Italy 

    Consulting Fees: Astra Zeneca, Daichii Sankyo, Ellipsis, Lilly, Merck, Novartis
    Commercial Interest Speakers Bureau: Novartis, Pfizer, Roche 

    Peter Schmid, FRCP, MD, PhD
    Centre Lead, Barts Cancer Institute 
    Queen Mary University of London
    London, England

    Consulting Fees: AstraZeneca, Bayer, Boehringer Ingelheim, Celgene, Eisai, Merck, Novartis, Pfizer, Puma, Roche
    Contracted Research: Genentech, Novartis, Oncogenex, Roche
    Other (Spouse Consultancy): Genentech, Roche

    Reviewers/Content Planners/Authors:

    • Jorge Bacigalupo has nothing to disclose.
    • Ann Early has nothing to disclose.
    • Barry A. Fiedel, PhD has nothing to disclose.
    • Amanda Hilferty has nothing to disclose.
    • Brian P. McDonough, MD, FAAFP has nothing to disclose.
  • Learning Objectives

    After participating in this educational activity, participants should be better able to:

    • Discuss the changing landscape that CDK 4/6 inhibitors bring to treatment of HR-positive/HER2-negative metastatic breast cancer.
    • Compare characteristics of data deriving from randomized, controlled clinical trials and those from real-world studies.  
    • Formulate strategies to incorporate real-world studies involving the use of CDK 4/6 inhibitors in broad populations of patients with HR-positive/HER2-negative metastatic breast cancer.
  • Target Audience

    This activity is designed to meet the educational needs of oncologists and other healthcare professionals involved in the care of patients with metastatic breast cancer in Europe.

  • Accreditation and Credit Designation Statements

    Global Learning Collaborative is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

    Global Learning Collaborative designates this enduring material for a maximum of .25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

  • Provider(s)/Educational Partner(s)

    AGILE - Academy for Interprofessional Learning and Education - designs, develops, and delivers education across a broad spectrum of diseases and clinical conditions. Our mission is to serve as a trusted source of clinical information that helps healthcare professionals improve competence, performance, and patient outcomes.

    This activity was codeveloped with La Fundación ECO para la Excelencia y Calidad en la Oncología (The ECO Foundation). The ECO Foundation is a nonprofit medical professional organization in Spain, founded by the majority of the oncology and hematology department heads of the leading cancer centers in Spain with a mission of guaranteeing excellence in cancer care by joining the efforts of leading experts in the field of oncology and hematology.

  • Commercial Support

    This activity is supported by an independent educational grant from Pfizer Inc.

  • Disclaimer

    The views and opinions expressed in this educational activity are those of the faculty and do not necessarily represent the views of GLC and AGILE. This presentation is not intended to define an exclusive course of patient management; the participant should use his/her clinical judgment, knowledge, experience, and diagnostic skills in applying or adopting for professional use any of the information provided herein. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patients’ conditions and possible contraindications or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities. Links to other sites may be provided as additional sources of information. Once you elect to link to a site outside of AGILE, you are subject to the terms and conditions of use, including copyright and licensing restriction, of that site.

    Reproduction Prohibited
    Reproduction of this material is not permitted without written permission from the copyright owner.

    Disclaimer: Some products discussed in this activity may not have received regulatory approval by the US FDA for the treatment of patients. The FDA has stated that “good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement.”

  • System Requirements

    Our site requires a computer, tablet or mobile device and a connection to the Internet. For best results, a high-speed Internet connection is recommended (DSL/cable). We also recommend using the latest version of your favorite browser to ensure compliance with W3C standards, such as Internet Explorer, Microsoft Edge, Chrome, Firefox or Safari. Users accustomed to IE8, IE9 IE10 are advised to update their browsers for the best experience.

  • Publication Dates

    Release Date:

    Expiration Date:

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