The NCCN
Breast Cancer
Clinical Practice Guidelines in Oncology
TM
Robert W. Carlson, MD; D. Craig Allred, MD;
Benjamin O. Anderson, MD; Harold J. Burstein, MD, PhD;
W. Bradford Carter, MD; Stephen B. Edge, MD;
John K. Erban, MD; William B. Farrar, MD;
Lori J. Goldstein, MD; William J. Gradishar, MD;
Daniel F. Hayes, MD; Clifford A. Hudis, MD;
Mohammad Jahanzeb, MD; Krystyna Kiel, MD;
Britt-Marie Ljung, MD; P. Kelly Marcom, MD;
Ingrid A. Mayer, MD; Beryl McCormick, MD;
Breast Cancer Clinical Practice Guidelines in
Oncology
Key Words
NCCN Clinical Practice Guidelines, breast cancer, chemotherapy,
breast-conserving therapy, adjuvant therapy, mastectomy, en-
docrine therapy, radiation, therapy, lobular carcinoma in situ,
ductal carcinoma in situ (JNCCN 2009;7:122–192)
NCCN Categories of Evidence and Consensus
Category 1:
The recommendation is based on high-level ev-
idence (e.g., randomized controlled trials) and there is uni-
form NCCN consensus.
Category 2A: The recommendation is based on lower-level
evidence and there is uniform NCCN consensus.
Category 2B: The recommendation is based on lower-level
evidence and there is nonuniform NCCN consensus (but
no major disagreement).
Category 3: The recommendation is based on any level of
evidence but reflects major disagreement.
All recommendations are category 2A unless otherwise
noted.
The Breast Cancer Clinical Practice Guidelines presented here
are the work of the members of the NCCN Breast Cancer
Clinical Practice Guidelines Panel. Categories of evidence were
assessed and are noted on the algorithms and in the text.
Although not explicitly stated at every decision point of the
Guidelines, patient participation in prospective clinical trials is
the preferred option of treatment for all stages of breast can-
cer. The full breast cancer guidelines are not printed in this is-
sue of JNCCN, but can be accessed online at www.nccn.org.
Clinical trials: The NCCN believes that the best management
for any cancer patient is in a clinical trial. Participation in
clinical trials is especially encouraged.
Please Note
These guidelines are a statement of consensus of the au-
thors regarding their views of currently accepted approaches
to treatment. Any clinician seeking to apply or consult
these 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 makes no representation
or warranties of any kind regarding their content, use, or ap-
plication and disclaims any responsibility for their appli-
cations or use in any way.
These guidelines are copyrighted by the National
Comprehensive Cancer Network. All rights reserved. These
guidelines and the illustrations herein may not be repro-
duced in any form without the express written permission
of the NCCN © 2009.
Disclosures for the NCCN Breast Cancer Guidelines
Panel
At the beginning of each NCCN guidelines panel meeting, panel
members disclosed any financial support they have received
from industry. Through 2008, this information was published in
an aggregate statement in JNCCN and online. Furthering
NCCN’s commitment to public transparency, this disclosure
process has now been expanded by listing all potential conflicts
of interest respective to each individual expert panel member.
Individual disclosures for the NCCN Breast Cancer Guidelines
Panel members can be found on page 192. (To view the most re-
cent version of these guidelines and accompanying disclosures,
visit the NCCN Web site at www.nccn.org.)
These guidelines are also available on the Internet. For the latest
update, please visit www.nccn.org.
122
Lisle M. Nabell, MD; Lori J. Pierce, MD; Elizabeth C. Reed, MD;
Mary Lou Smith, JD, MBA; George Somlo, MD;
Richard L. Theriault, DO, MBA; Neal S. Topham, MD;
John H. Ward, MD; Eric P. Winer, MD;
and Antonio C. Wolff, MD
Overview
The American Cancer Society estimated that 184,450
new cases of invasive breast cancer would be diag-
nosed and 40,930 patients would die of the disease in
the United States in
2008.
1
In addition, approximately
67,770 women will be diagnosed with carcinoma in situ
of the breast during the same year. Breast cancer is the
© Journal of the National Comprehensive Cancer Network Volume 7 Number 2 February 2009
Breast Cancer
NCCN
Clinical Practice Guidelines
Journal of the National Comprehensive Cancer Network
123
NCCN Breast Cancer Panel Members
*Robert W. Carlson, MD/Chair†
Stanford Comprehensive Cancer Center
D. Craig Allred, MD⫽
Siteman Cancer Center at Barnes-Jewish Hospital and
Washington University School of Medicine
*Benjamin O. Anderson, MD¶
Fred Hutchinson Cancer Research Center/
Seattle Cancer Care Alliance
Harold J. Burstein, MD, PhD†
Dana-Farber/Brigham and Women’s Cancer Center
W. Bradford Carter, MD¶
H. Lee Moffitt Cancer Center & Research Institute
*Stephen B. Edge, MD¶
Roswell Park Cancer Institute
John K. Erban, MD†
Massachusetts General Hospital Cancer Center
William B. Farrar, MD¶
Arthur G. James Cancer Hospital & Richard J. Solove
Research Institute at The Ohio State University
Lori J. Goldstein, MD†
Fox Chase Cancer Center
William J. Gradishar, MD‡
Robert H. Lurie Comprehensive Cancer Center of
Northwestern University
Daniel F. Hayes, MD†
University of Michigan Comprehensive Cancer Center
Clifford A. Hudis, MD†
Memorial Sloan-Kettering Cancer Center
Mohammad Jahanzeb, MD‡
St. Jude Children’s Research Hospital/
University of Tennessee Cancer Institute
Krystyna Kiel, MD§
Robert H. Lurie Comprehensive Cancer Center of
Northwestern University
Britt-Marie Ljung, MD⫽
UCSF Helen Diller Family Comprehensive Cancer Center
P. Kelly Marcom, MD†
Duke Comprehensive Cancer Center
Ingrid A. Mayer, MD†
Vanderbilt-Ingram Cancer Center
*Beryl McCormick, MD§
Memorial Sloan-Kettering Cancer Center
Lisle M. Nabell, MD‡
University of Alabama at Birmingham
Comprehensive Cancer Center
Lori J. Pierce, MD§
University of Michigan Comprehensive
Cancer Center
Elizabeth C. Reed, MD†
UNMC Eppley Cancer Center at
The Nebraska Medical Center
*Mary Lou Smith, JD, MBA¥
Consultant
George Somlo, MD‡
City of Hope Comprehensive Cancer Center
*Richard L. Theriault, DO, MBA†
The University of Texas M. D. Anderson Cancer Center
*Neal S. Topham, MDŸ
Fox Chase Cancer Center
John H. Ward, MD‡
Huntsman Cancer Institute at the University of Utah
Eric P. Winer, MD†
Dana-Farber/Brigham and Women’s Cancer Center
Antonio C. Wolff, MD†
The Sidney Kimmel Comprehensive Cancer Center at
Johns Hopkins University
KEY:
*Writing Committee Member
Specialties: †Medical Oncology; ⫽Pathology;
¶Surgical Oncology; ‡Hematology/Oncology;
§Radiation Oncology; Bone Marrow Transplantation;
¥Patient Advocacy; ŸReconstructive Surgery
Text continues on p. 157
most common malignancy in women in the United
States and is second only to lung cancer as a cause of
cancer death.
The incidence of breast cancer has increased
steadily in the United States over the past few decades,
but breast cancer mortality seems to be declining,
1,2
suggesting a benefit from early detection and more ef-
fective treatment.
The etiology of most breast cancer cases is un-
known. However, numerous risk factors for the dis-
ease have been established, including female gender,
increasing patient age,
family h
istory of breast cancer
at a young age, early menarche, late menopause, older
age at first live childbirth, prolonged hormone re-
placement therapy, previous exposure to therapeutic
chest wall irradiation, benign proliferative breast dis-
ease, and genetic mutations, such as of the BRCA1/2
genes. However, except for female gender and in-
creasing patient age, these risk factors are associated
with
o
nly few breast cancers. Women with a strong
family history of breast cancer should be evaluated
according to the NCCN Clinical Practice Guidelines
in Oncology: Genetic/Familial High-Risk Assessment:
Breast and Ovarian (to see the most recent version of
these guidelines, visit the NCCN Web site at www.
nccn.org). Women at increased risk for breast cancer
(generally those with a ≥ 1.67% 5-year risk us
ing t
he
Gail model of risk assessment
3
) may consider risk
© Journal of the National Comprehensive Cancer Network Volume 7 Number 2 February 2009
INVASIVE BREAST CANCER Breast Cancer Version 1:2009
Clinical trials: The NCCN believes that the best management for any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
All recommendations are category 2A unless otherwise noted.
124 Clinical Practice Guidelines
© Journal of the National Comprehensive Cancer Network
Volume 7 Number 2 February 2009
Breast Cancer Version 1:2009 INVASIVE BREAST CANCER
Version 1.2009, 12-02-08 ©2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be
reproduced in any form without the express written permission of NCCN.
© Journal of the National Comprehensive Cancer Network Volume 7 Number 2 February 2009
NCCN Clinical Practice Guidelines in Oncology 125
143)
INVASIVE BREAST CANCER Breast Cancer Version 1:2009
Clinical trials: The NCCN believes that the best management for any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
All recommendations are category 2A unless otherwise noted.
126 Clinical Practice Guidelines
© Journal of the National Comprehensive Cancer Network
Volume 7 Number 2 February 2009