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NCCN Clinical Practice Guidelines in Oncology™
Breast Cancer
V.1.2009
www.nccn.org
Version 1.2009 12/02/2008 © 2008 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.
Guidelines Index
Breast Cancer TOC
Staging, Discussion, References
Practice Guidelines
in Oncology – v.1.2009NCCN
®
NCCN Breast Cancer Panel Members
Robert W. Carlson, MD/Chair †
Stanford Comprehensive Cancer Center
D. Craig Allred, MD
†
William J. Gradishar, MD ‡
Robert H. Lurie Comprehensive Cancer
Center of Northwestern University
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
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
Richard L. Theriault, DO, MBA †
The University of Texas M. D. Anderson
Cancer Center
Neal S. Topham, MD
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 | Massachusetts General Hospital
Cancer Center
Antonio C. Wolff, MD †
The Sidney Kimmel Comprehensive Cancer
Center at Johns Hopkins University
Ÿ
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
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Breast Cancer
*
† Medical Oncology
‡ Hematology/Oncology
¶ Surgical Oncology
Pathology
Ÿ Reconstructive Surgery
§ Radiation Oncology
Bone Marrow Transplantation
¥ Patient Advocacy
* Writing Committee Member
NCCN Guidelines Panel Disclosures
*
*
*
*
*
*
Version 1.2009 12/02/2008 © 2008 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.
Guidelines Index
Breast Cancer TOC
Staging, Discussion, References
Practice Guidelines
in Oncology – v.1.2009NCCN
®
Table of Contents
Noninvasive Breast Cancer
Invasive Breast Cancer
NCCN Breast Cancer Panel Members
Summary of Guidelines Updates
Lobular Carcinoma In Situ (LCIS-1)
Ductal Carcinoma In Situ (DCIS-1)
Clinical Stage, Workup (BINV-1)
Locoregional Treatment of Clinical Stage l, llA,
or llB Disease or T3,N1,M0 (BINV-2)
Systemic Adjuvant Treatment (BINV-4)
Preoperative Chemotherapy Guideline
Clinical Stage llA, llB, Workup (BINV-10)
Primary Treatment, Adjuvant Treatment
(BINV-11)
Clinical Stage lllA, lllB, lllC, and Stage IV,
Workup (BINV-13)
Preoperative Chemotherapy, Locoregional
Treatment, Adjuvant Treatment (BINV-14)
Surveillance/Follow-Up, Recurrence Workup or
Initial Workup for Stage lV Disease (BINV-15)
Treatment of Recurrence/Stage IV Disease
(BINV-16)
Principles of HER2 Testing (BINV-A)
Principles of Dedicated Breast MRI Testing
(BINV-B)
These 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 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 representations nor warranties
of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. These
guidelines are copyrighted by National Comprehensive Cancer Network. All rights reserved. These guidelines and the illustrations herein may not
be reproduced in any form without the express written permission of NCCN. ©2008.
For help using these
documents, please click here
Guidelines Index
Print the Breast Cancer Guideline
Staging
Manuscript
References
Clinical Trials:
Categories of Evidence and
Consensus:
NCCN
The
believes that the best management
for any cancer patient is in a clinical
trial. Participation in clinical trials is
especially encouraged.
To find clinical trials online at NCCN
member institutions,
All recommendations
are Category 2A unless otherwise
specified.
See
NCCN
click here:
nccn.org/clinical_trials/physician.html
NCCN Categories of Evidence
and Consensus
Invasive Breast Cancer (continued)
Special Considerations
Surgical Axillary Staging - Stage l, llA ,
and llB (BINV-C)
Axillary Lymph Node Staging (BINV-D)
Margin Status in Infiltrating Carcinoma
(BINV-E)
Special Considerations to Breast-
Conserving Therapy Requiring Radiation
Therapy (BINV-F)
Principles of Breast Reconstruction
Following Mastectomy (BINV-G)
Principles of Radiation Therapy (BINV-H)
Adjuvant Endocrine Therapy (BINV-I)
Adjuvant Chemotherapy (BINV-J)
Definition of Menopause (BINV-K)
Subsequent Endocrine Therapy (BINV-L)
Preferred Chemotherapy Regimens for
Recurrent or Metastatic Breast Cancer
(BINV-M)
Phyllodes Tumor (PHYLL-1)
Paget’s Disease (PAGET-1)
Breast Cancer During Pregnancy (PREG-1)
Inflammatory Breast Cancer (IBC-1)
Breast Cancer
Version 1.2009 12/02/2008 © 2008 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.
Guidelines Index
Breast Cancer TOC
Staging, Discussion, References
Practice Guidelines
in Oncology – v.1.2009NCCN
®
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
UPDATES
Breast Cancer Update Summary
DCIS-1
BINV-1
BINV-2
BINV-5
BINV-7
BINV-7
BINV-9
BINV-10
BINV-12
BINV-14
BINV-13
BINV-15
BINV-14
Under the work-up section, added recommendation for genetic counseling if the
patient is high risk for hereditary breast cancer.
Footnote h added: “Post-excision mammography should also be performed
whenever uncertainty about adequacy of excision remains.”
Changed recommendation for radiation therapy to whole breast with “or without”
boost following lumpectomy.
Added ± trastuzumab as a category 3 recommendation for systemic adjuvant
treatment for tumors 0.6-1.0 cm, moderate/poorly differentiated or unfavorable
features. Also added to .
Footnote u is new to the page: “The prognosis of patients with T1a and T1b tumors
that are node negative is generally favorable even when HER2 is amplified or over-
expressed. This is a population of breast cancer patients that was not studied in the
available randomized trials. The decision for use of trastuzumab therapy in this
cohort of patients must balance the known toxicities of trastuzumab, such as
cardiac toxicity, and the uncertain, absolute benefits that may exist with trastuzumab
therapy.” Also added to .
Added repeat determination of tumor estrogen/progesterone receptor (ER/PR) status
following ER/PR negative.
Under the work-up section, added recommendation for genetic counseling if the
patient is high risk for hereditary breast cancer.
Footnote d is new to the page: “The use of PET/CT scanning is not indicated in the
staging of clinical stage I, II, or operable III breast cancer.”
Footnote d is new to the page: “The use of PET/CT scanning is not indicated in the
staging of clinical stage I, II, or operable III breast cancer.”
Added “Complete up to one year of trastuzumab therapy if HER2-positive (category
1). May be administered concurrent with radiation therapy and with endocrine
therapy if indicated. If capecitabine administered as a radiation sensitizer,
trastuzumab may be given concurrent with the capecitabine.” under adjuvant
treatment. Also added to .
Footnote z is new to the page: “The use of PET or PET/CT scanning should
generally be discouraged for the evaluation of locally advanced disease except in
those clinical situations where other staging studies are equivocal or suspicious.
Even in these situations, biopsy of equivocal or suspicious sites is more likely to
provide useful information. Also added to
Footnote w has been revised: “Patients with HER2 positive tumors should be
treated with preoperative chemotherapy incorporating trastuzumab for at least 9
weeks of preoperative therapy.”
bone mineral density determination at baseline and periodically
thereafter” to surveillance/follow-up.
Footnote aa is new to the page: “The use of estrogen, progesterone, or selective
estrogen receptor modulators to treat osteoporosis or osteopenia in women with
breast cancer is discouraged. The use of a bisphosphonate is generally the
preferred intervention to improve bone mineral density. Current clinical trials
support the use of bisphosphonate for up to 2 years. Longer duration of
bisphosphonate therapy may provide additional benefit, but this has not yet been
tested in clinical trials. Women treated with a bisphosphonate should undergo a
dental examination with preventive dentistry prior to the initiation of therapy, and
should take supplemental calcium (1200-1500 mg/day) and vitamin D (400-800
IU/day).”
Footnote ff is new to the page: “Women presenting at time of initial diagnosis with
metastatic disease may benefit from the performance of local breast surgery and/’or
radiation therapy. Generally this palliative local therapy should be considered only
after response to initial systemic therapy.”
Added “...
Added a new pathway for local recurrence with initial treatment mastectomy and no
prior radiation therapy.
Footnote hh is new to the page: False negative ER and/or PR determinations occur,
and there may be discordance between the ER and/or the PR determination between
the primary and metastatic tumor(s). Therefor, endocrine therapy with its low
attendant toxicity may be considered in patients with non-visceral or asymptomatic
visceral tumors. especially in patients with clinical characteristics predicting for a
hormone receptor positive tumor (eg, long disease free interval, limited sites of
recurrence, indolent disease, or older age). Also added to .
Principles of Dedicated Breast MRI Testing - this page has been updated and
includes 6 new bulleted recommendations.
New title “Principles of Breast Reconstruction Following Surgery” includes 2 new
recommendations for cosmetic outcome before and after surgery.
and
Chemotherapy pages were reorganized, dose schedules provided and references
updated.
Footnote c has been revised: “There are insufficient data to recommend general use
of sentinel node procedures, a taxane or trastuzumab during pregnancy.
BINV-15
BINV-16
BINV-18
BINV-19
BINV-B
BINV-G
BINV-J BINV-M
PREG-1
BINV-17
Summary of changes in the 1.2009 version of the NCCN Breast Cancer Guidelines from the 2.2008 version include:
Version 1.2009 12/02/2008 © 2008 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.
Guidelines Index
Breast Cancer TOC
Staging, Discussion, References
Practice Guidelines
in Oncology – v.1.2009NCCN
®
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
LCIS-1
Lobular Carcinoma in Situ
WORKUPDIAGNOSIS PRIMARY
TREATMENT
RISK REDUCTION SURVEILLANCE/FOLLOW-UP
Lobular carcinoma
in situ (LCIS)
Stage 0
Tis, N0, M0a
History and physical
Diagnostic bilateral
mammogram
Pathology reviewb
Observationc
Counseling regarding risk
reduction with tamoxifen for
premenopausal women, or
with tamoxifen or raloxifene
for postmenopausal women
(category 1, see also
or
In special circumstances,
bilateral mastectomy (see also
±
reconstruction may be
considered for risk reduction
d
e
NCCN
Breast Cancer Risk Reduction
Guidelines
NCCN Breast Cancer Risk
Reduction Guidelines
)
)
Interval history and physical
exam every 6-12 mo
Mammogram every 12 mo,
unless postbilateral
mastectomy
If treated with tamoxifen,
monitor per NCCN Breast
Cancer Risk Reduction
Guidelines
a
b
c
d
e
The panel endorses the College of American Pathology Protocol for pathology reporting for all invasive and non-invasive carcinomas of the breast.
Histologically aggressive va iants of LCIS ("pleomorphic LCIS") may have a si i ar biological behavior to that of DCIS, but outcome data regarding the efficacy of
surgical excision to negative margins and/or radiotherapy are lacking.
Some serotonin reuptake inhibitors decrease the formation of endoxifen, an active metabolite of tamoxifen. However, citalopram and venlafaxine appear to have
minimal impact on tamoxifen metabolism. The clinical impact of these observations is not known.
r m l
See NCCN Breast Cancer Screening and Diagnosis Guidelines.
http://www.cap.org
See Principles of Breast Reconstruction Following Surgery (BINV-G).
...
