Statement of Need/Target Audience

Breast cancer is one of the most rapidly evolving fields in medical oncology. Published results from clinical trials lead to the emergence of new therapeutic agents and changes in the indications for existing treatments. In order to offer optimal patient care, the practicing medical oncologist must be well informed of ongoing and proposed clinical trials, as these offer meaningful therapeutic options to many patients. This CME program is intended to inform and update medical oncologists on breast cancer clinical trials and to encourage their enrollment of appropriately selected patients in these studies.

Global Learning Objectives

• Describe ongoing and planned clinical trials in the adjuvant, neoadjuvant and metastatic settings and counsel appropriately selected patients about the availability of ongoing clinical trials.
• Explain hormonal therapy treatment strategies currently under evaluation for both pre- and postmenopausal patients with ER-positive breast cancer.
• Describe the rationale for and design of ongoing clinical trials of various chemotherapeutic agents, including trials evaluating dose-dense chemotherapy regimens.
• Evaluate treatment strategies combining biologic agents with chemotherapy, endocrine therapy and other biologic agents in planned and ongoing clinical trials.
• Discuss the utility of genomic markers as a tool for determining whether to administer chemotherapy in combination with hormonal therapy for postmenopausal patients with ER-positive breast cancer.
• Describe the results of the large clinical trials evaluating adjuvant trastuzumab in patients with HER2-positive breast cancer as a model for future clinical research.

Purpose of this Breast Cancer Clinical Trials Guide

The purpose of this special edition of Breast Cancer Update is to support these global objectives by offering the perspectives of Drs Sledge, Wolmark, Hudis, Gralow, Robertson and Perez on the integration of emerging clinical research data and available clinical trials into the management of breast cancer.

Accreditation Statement

Research To Practice is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Credit Designation Statement

Research To Practice designates this educational activity for a maximum of 4 AMA PRA Category 1 Credit(s)™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

How to Use this CME Activity

This CME activity contains both audio and print components. To receive credit, the participant should listen to the CDs, review the monograph and complete the Post-test and Evaluation Form located in the back of this monograph or on our website. This monograph contains edited comments, clinical trial schemas, graphics and references that supplement the audio program. BreastCancerUpdate.com/ClinicalTrials includes an easy-to-use, interactive version of this monograph with links to relevant full-text articles, abstracts, trial information and other web resources indicated here in blue underlined text.

Comments from clinical investigators in this monograph, unless otherwise noted, are from Breast Cancer Update and associated audio programs. Please visit BreastCancerUpdate.com for more.

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Editor’s Note:
Let’s get this thing done.

Prologue:
The adjuvant trastuzumab clinical research to practice model
- Select publications

Breast Cancer Clinical Trials:

Neoadjuvant Therapy

Radiation Therapy

Adjuvant Endocrine Therapy

Adjuvant Chemotherapy

Metastatic Disease

Future Trial Concepts

Study Contacts

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CME Information

Faculty Disclosures

Editor's Office