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(NCCN) Breast Cancer Clinical Practice Guidelines NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Breast Cancer Version 5.2020 — July 15, 2020 NCCN.org NCCN Guidelines for Patients® available at www.nccn.org/patients Continue Version 5.2020, 07/15/20 © 2020 National Comprehensive Cancer Network® (NCCN®), All rights reserved. NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN. NCCN Guidelines Index NCCN Guidelines Version 5.2020 Table of Contents Breast Cancer Discussion *William J. Gradishar, MD/Chair ‡ † Sharon H. Giordano, MD, MPH † Sameer A. Patel, MD Ÿ Robert H. Lurie Comprehensive Cancer The University of Texas Fox Chase Cancer Center Center of Northwestern University MD Anderson Cancer Center Lori J. Pierce, MD § *Benjamin O. Anderson, MD/Vice-Chair ¶ Matthew P. Goetz, MD ‡ † University of Michigan Fred Hutchinson Cancer Research Mayo Clinic Cancer Center Rogel Cancer Center Center/Seattle Cancer Care Alliance Lori J. Goldstein, MD † Hope S. Rugo, MD † Jame Abraham, MD ‡ † Fox Chase Cancer Center UCSF Helen Diller Family Case Comprehensive Cancer Center/ Comprehensive Cancer Center Steven J. Isakoff, MD, PhD † University Hospitals Seidman Cancer Center Massachusetts General Hospital Amy Sitapati, MD Þ and Cleveland Clinic Taussig Cancer Institute Cancer Center UC San Diego Moores Cancer Center Rebecca Aft, MD, PhD ¶ Jairam Krishnamurthy, MD † Karen Lisa Smith, MD, MPH † Siteman Cancer Center at Barnes- Fred & Pamela Buffet Cancer Center The Sidney Kimmel Comprehensive Jewish Hospital and Washington Cancer Center at Johns Hopkins University School of Medicine Janice Lyons, MD § Case Comprehensive Cancer Center/ Mary Lou Smith, JD, MBA ¥ Doreen Agnese, MD ¶ University Hospitals Seidman Cancer Center Research Advocacy Network The Ohio State University Comprehensive and Cleveland Clinic Taussig Cancer Institute Cancer Center - James Cancer Hospital Hatem Soliman, MD † and Solove Research Institute P. Kelly Marcom, MD † Moffitt Cancer Center Duke Cancer Institute Kimberly H. Allison, MD ≠ Erica M. Stringer-Reasor, MD † ‡ Stanford Cancer Institute Jennifer Matro, MD † O'Neal Comprehensive Abramson Cancer Center at the Cancer Center at UAB Sarah L. Blair, MD ¶ University of Pennsylvania UC San Diego Moores Cancer Center Melinda L. Telli, MD † Þ Ingrid A. Mayer, MD † Stanford Cancer Institute Harold J. Burstein, MD, PhD † Vanderbilt-Ingram Cancer Center Dana-Farber/Brigham and Women’s John H. Ward, MD ‡ † Cancer Center Meena S. Moran, MD § Huntsman Cancer Institute Yale Cancer Center/Smilow Cancer Hospital at the University of Utah Chau Dang, MD † Memorial Sloan Kettering Cancer Center Joanne Mortimer, MD † Jessica S. Young, MD ¶ City of Hope National Medical Center Roswell Park Comprehensive Cancer Center Anthony D. Elias, MD † University of Colorado Cancer Center Ruth M. O'Regan, MD † University of Wisconsin Carbone Cancer Center NCCN ‡ Hematology/Hematology § Radiation oncology/ Rashmi Kumar, PhD oncology Radiotherapy Jennifer Burns Continue Þ Internal medicine Ÿ Reconstructive surgery † Medical oncology ¶ Surgery/Surgical oncology ≠ Pathology * Discussion Section Writing NCCN Guidelines Panel Disclosures ¥ Patient advocacy Committee Version 5.2020, 07/15/20 © 2020 National Comprehensive Cancer Network® (NCCN®), All rights reserved. NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN. NCCN Guidelines Index NCCN Guidelines Version 5.2020 Table of Contents Breast Cancer Discussion NCCN Breast Cancer Panel Members Principles of Biomarker Testing (BINV-A) Summary of Guidelines Updates Principles of Dedicated Breast MRI Testing (BINV-B) Clinical Trials: NCCN believes Fertility and Birth Control (BINV-C) that the best management for any Recommendations for Lobular Carcinoma In Situ were patient with cancer is in a clinical removed from the NCCN Guidelines for Breast Cancer, Surgical Axillary Staging (BINV-D) Axillary Lymph Node Staging (BINV-E) trial. See NCCN Guidelines for Breast Screening and Diagnosis Participation in clinical trials is M argin Status Recommendations for DCIS and Invasive especially encouraged. Noninvasive Breast Cancer: Breast Cancer (BINV-F) D uctal Carcinoma In Situ (DCIS) Workup and Primary Special Considerations to Breast-Conserving Therapy To find clinical trials online at Treatment (DCIS-1) Requiring RT (BINV-G) NCCN Member Institutions, DCIS Postsurgical Treatment and Surveillance/Follow-up (DCIS-2) P rinciples of Breast Reconstruction Following click here: nccn.org/clinical_trials/member_ Invasive Breast Cancer: Surgery (BINV-H) Clinical Stage, Workup (BINV-1) Principles of Radiation Therapy (BINV-I) institutions.aspx. Locoregional Treatment of T1–3,N0–1,M0 Disease (BINV-2) Special Considerations for Breast Cancer in Men (BINV-J) NCCN Categories of Systemic Adjuvant Treatment Adjuvant Endocrine Therapy (BINV-K) Evidence and Consensus: All • Hormone Receptor-Positive HER2-Positive Disease (BINV-5) Preoperative/Adjuvant Therapy Regimens (BINV-L) recommendations are category • N ode-Negative Hormone Receptor-Positive HER2-Negative Principles of Preoperative Systemic Therapy (BINV-M) 2A unless otherwise indicated. Disease (BINV-6) G ene Expression Assays for Consideration of Addition of Adjuvant Systemic Chemotherapy to Adjuvant Endocrine See NCCN Categories of • N ode-Positive Hormone Receptor-Positive HER2-Negative Evidence and Consensus. Disease (BINV-7) Therapy (BINV-N) • Hormone Receptor-Negative HER2-Positive Disease (BINV-8) Definition of Menopause (BINV-O) S ystemic Therapy for ER- and/or PR-Positive Recurrent or NCCN Categories of • Hormone Receptor-Negative HER2-Negative Disease (BINV-9) Preference: • Favorable Histologies (BINV-10) Stage IV (M1) Disease (BINV-P) S ystemic Therapy Regimens for Recurrent or Stage IV All recommendations are Workup Prior to Preoperative Systemic Therapy (BINV-11) considered appropriate. A djuvant Systemic Therapy After Preoperative (M1) Disease (BINV-Q) Systemic Therapy (BINV-15) A dditional Targeted Therapies and Associated Biomarker See NCCN Categories of Surveillance/Follow-Up (BINV-16) Testing for Recurrent or Stage IV (M1) Disease (BINV-R) Preference. Recurrent/Stage IV (M1) Disease (BINV-17) Principles of Monitoring Metastatic Disease (BINV-S) Treatment of Local and Regional Recurrence (BINV-18) Special Considerations: Systemic Treatment of Recurrent or Stage IV (M1) Disease (BINV-19) Phyllodes Tumor (PHYLL-1) Paget’s Disease (PAGET-1) Breast Cancer During Pregnancy (PREG-1) Inflammatory Breast Cancer (IBC-1) Staging (ST-1) The NCCN Guidelines® are a statement of evidence and consensus of the authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult the NCCN Guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment. The National Comprehensive Cancer Network® (NCCN®) makes no representations or warranties of any kind regarding their content, use or application and disclaims any responsibility for their application or use in any way. The NCCN Guidelines are copyrighted by National Comprehensive Cancer Network®. All rights reserved. The NCCN Guidelines and the illustrations herein may not be reproduced in any form without the express written permission of NCCN. ©2020. Version 5.2020, 07/15/20 © 2020 National Comprehensive Cancer Network® (NCCN®), All rights reserved. NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN. NCCN Guidelines Index NCCN Guidelines Version 5.2020 Table of Contents Breast Cancer Discussion Updates in Version 5.2020 of the NCCN Guidelines for Breast Cancer from Version 4.2020 include: BINV-L & BINV-Q • Preoperative/adjuvant therapy for HER2-positive disease and sytemic therapy for HER2-positive recurrent or stage IV (M1) disease: Footnote added: Pertuzumab, trastuzumab, and hyaluronidase-zzxf injection for subcutaneous use may be substituted anywhere that the combination of intravenous pertuzumab and intravenous trastuzumab are given as part of systemic therapy. Pertuzumab, trastuzumab, and hyaluronidase-zzxf injection for subcutaneous use has different dosing and administration instructions compared to the intravenous products. Continued Version 5.2020, 07/15/20 © 2020 National Comprehensive Cancer Network® (NCCN®), All rights reserved. NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN. UPDATES NCCN Guidelines Index NCCN Guidelines Version 5.2020 Table of Contents Breast Cancer Discussion Updates in Version 4.2020 of the NCCN Guidelines for Breast Cancer from Version 3.2020 include: BINV-Q • Recurrent or stage IV (M1) Disease Added sacituzumab govitecan-hziy as an other recommended regimen for triple negative breast cancer (TNBC), with the following footnote: For adult patients with metastatic TNBC who received at least two prior therapies for metastatic disease. (BINV-Q, 1 of 7) Added tucatinib + trastuzumab + capecitabine (category 1) as an other recommended regimen for HER2-positive disease, with the following footnote: For adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more lines of prior HER2-targeted therapy in the metastatic setting. (BINV-Q, 2 of 7) • Dose/administration and references updated to include newly added regimens.
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