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at the National Institutes of Health


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Personal history of breast cancer

Prior radiation therapy

Dense breast tissue

Other risk factors and risk prediction models

Breast Cancer Diagnosis and Patholog y

Evaluation of Breast Symptoms

Pathologic Diagnosis of Breast Cancer

Ductal Carcinoma In Situ

Breast Cancer Screening Concepts

Bias

Assessment of Performance and Accuracy

Sensitivity

Specificity and false-positive rate

Interval cancers

Breast Cancer Screening Modalities—Mammography

Mammography Description and Background

Benefit of Mammography

Randomized controlled trials Summary of RCTs

Effectiveness of Population-Based Screening Programs

Statistical Modeling of Breast Cancer Incidence and Mortality in the Uni

Characteristics of Cancers Detected by Screening Mammography

Mammography—Variables Associated with Accuracy

Patient Characteristics

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ed States

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Tumor Characteristics

Physician Characteristics

Facility Characteristics

International ComparisonsPrevalent Versus Subsequent Examination and the Interval Between Ex

Digital Mammography

Mammography and Computer-Aided Detection (CAD)

Harms of Screening Mammography

False-Positives Leading to Possible Additional InterventionsOverdiagnosis

False-Negatives Leading to Possible False Sense of Security

Discomfort

Radiation Exposure

Anxiety

Breast Cancer Screening Modalities—Beyond Mammography

Clinical Breast Examination

Breast Self-examination

Ultrasonography

Magnetic Resonance Imaging

Thermography

Tissue Sampling (Fine-Needle Aspiration, Nipple Aspirate, Ductal Lava

Special Populations

Individuals With Little to Gain from Screening

Women with limited life expectancy

Elderly women

Young women

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ms

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Men

Individuals at Increased Risk of Breast Cancer and Thus Possibly With

Women who have received thoracic radiation

Race

Appendix of Randomized Controlled Trials

Changes to This Summary (08/29/2014)

Questions or Comments About This Summary

About This PDQ Summary

Purpose of This Summary

Reviewers and Updates

Levels of Evidence

Permission to Use This Summary Disclaimer

Contact Us

Get More Information From NCI

Overview

Note: Separate PDQ summaries on Breast Cancer Prevention, Breast Can

Treatment, and Breast Cancer Treatment and Pregnancy are also availabl

This summary covers the topic of breast cancer screening and includes in

incidence and mortality, risk factors for breast cancer, the process of brea

and harms of various breast cancer screening modalities. This summary a

screening among special populations.

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ore to Gain From Screening

er Treatment, Male Breast Cancer

.

rmation about breast cancer

t cancer diagnosis, and the benefits

so includes information about

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Mammography is the most widely used screening modality, with solid evi

to 74 years. Clinical breast examination and breast self-exam have also be

benefit. Technologies such as ultrasound, magnetic resonance imaging, to

imaging are being evaluated, usually as adjuncts to mammography.

Screening With Mammography

Benefits

Based on solid evidence, screening mammography may lead to the followi

Decrease in breast cancer mortality

Magnitude of Effect: In the randomized controlled trials (

years, screening with mammography has been associated wit

in mortality due to breast cancer.[1] Absolute mortality bene

10 years is approximately 1% overall, ranging from 4 per 10,

age 40 years to 50 per 10,000 women who start at age 50 ye

up from the Canadian National Breast Screening Study (CNB

screening,[3] there is some uncertainty about the magnitudepresent day.

Study Design: RCTs, population-based evidence.

Internal Validity : Variable, but meta-analysis of RCTs goo

Consistency : Fair.

External Validity : Good.

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ence of benefit for women aged 40

n evaluated but are of uncertain

osynthesis, and molecular breast

g benefit:

CTs), for women aged 40 to 74

h a 15% to 20% relative reduction

it for women screened annually for

00 women who start screening at

rs.[2] Based on the 25-year follow-

SS), an RCT of breast cancer

of benefit of mammography in the

.

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g harms:

ncers: Diagnosis of cancers that

s lifetime can expose a woman to

radiation therapy, hormone

fects of therapeutic radiation (new

cy, and tumor type (ductal

detected by screening

iagnosis.[6] The best estimations

Ts of screening or the calculation of

are uncertainties with each

ted excess incidence studies in the

% of screen-detected breast

utopsy series, and series of

called from each screening

recalled will have cancer.[10]

in the United States will

sies.[11,12] Additional testing is

ison.

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False-Negatives with False Sense of Security and Potential

Magnitude of Effect: 6% to 46% of women with invasive c

mammograms, especially if they are young, have dense breas

lobular, or rapidly growing cancers.[15]

Study design: Descriptive population-based.

Radiation-Induced Breast Cancer: Radiation-induced mutatio

especially if exposure occurs before age 30 years and is at high dose

therapy for Hodgkin disease. The breast dose associated with a typiapproximately 4 mSv and extremely unlikely to cause cancer. One

mammograms. Latency is at least 8 years, and the increased risk is

Magnitude of Effect: Theoretically, annual mammograms

cause up to one breast cancer per 1,000 women.[16,17]

Study design: Descriptive population-based.

For all these potential harms of screening mammography, internal validit

are good.

Clinical Breast Examination

Benefits

Clinical breast examination (CBE) has not been tested independently; it w

mammography in one Canadian trial, and was the comparator modality v

trial. Thus, it is not possible to assess the efficacy of CBE as a screening musual care (no screening activity).

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Delay in Cancer Diagnosis.

ncer will have negative

s,[13,14] or have mucinous,

ns can cause breast cancer,

s, such as from mantle radiation

al two-view mammogram isv is equivalent to 200

ifelong.[16,17]

in women aged 40 to 80 years may

, consistency and external validity

as used in conjunction with

rsus mammography in another

dality when it is used alone versus

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Magnitude of Effect: The current evidence is insufficient to asse

of CBE. The single RCT comparing high-quality CBE to screening

benefit for both modalities. Accuracy in the community setting mig

Study Design: Single RCT, population cohort studies.

Internal Validity : Good.

Consistency and External Validity : Poor.

Harms

Screening by CBE may lead to the following harms:

False-Positives with Additional Testing and Anxiety.

Magnitude of effect: Specificity in women aged 50 to 59 y

false-positive rate of 1% to 12%.[18]

Study Design: Descriptive population-based.

Internal Validity, Consistency and External Validity :

False-Negatives with Potential False Reassurance and Del

Magnitude of Effect: Of women with cancer, 17% to 43%

higher with longer duration and higher quality of the examin

Study Design: Descriptive population-based.

Internal and External Validity : Good.

Consistency : Fair.



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s the additional benefits and harms

ammography showed equivalent

t be lower than in the RCT.

ars was 88% to 99%, yielding a

Good.

y in Cancer Diagnosis.

ave a negative CBE. Sensitivity is

tion by trained personnel.


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-

Benefits

Breast self-examination (BSE) has been compared to usual care (no scree

shown to reduce breast cancer mortality.

Magnitude of Effect: No effect.[19,20]

Study Design: Two RCTs.

Internal Validity and Consistency : Fair.

External Validity : Poor.

Harms

Based on solid evidence, formal instruction and encouragement to perfor

and diagnosis of more benign breast lesions.

Magnitude of Effects on Health Outcomes: Biopsy rate was 1.

compared with 1.0% among the control group.[19]

Study Design: Two RCTs, cohort studies.

Internal Validity : Good.

Consistency : Fair.

External Validity : Poor.

References

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ing activity) and has not been

BSE leads to more breast biopsies

8% among the study population


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Description of the Evidence

Background

Breast cancer incidence and mortality

Breast cancer is the most common noncutaneous cancer in U.S. women,

situ disease, 232,670 new cases of invasive disease, and 40,000 deaths ex

1 of 6 women diagnosed with breast cancer die of the disease. By compari

are estimated to die of lung cancer in 2014.[1] Males account for 1% of bre

deaths (refer to the Special Populations section of this summary for more

Widespread adoption of screening increases breast cancer incidence in acharacteristics of cancers detected, with increased incidence of lower-risk

http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/Page10#Section_123http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference2.1http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12359854&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=17356964&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9440762&dopt=Abstract


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examination in community

-examination in Shanghai: final

rospective randomized

ance of self-examination for the

[PUBMED Abstract]

ith an estimated 62,570 cases of in

ected in 2014.[1] Thus, fewer than

on, about 72,330 American women

ast cancer cases and breast cancer

nformation).

iven population and changes thecancers, premalignant lesions, and

http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference2.1http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=14569932&dopt=Abstract


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ductal carcinoma in situ (DCIS). (Refer to the Ductal Carcinoma In Situ s

Diagnosis and Pathology section of this summary for more information.)

States [2] and the United Kingdom [3] demonstrate an increase in DCIS a

since the 1970s, attributable to the widespread adoption of both postmen

screening mammography. In the last decade, women have refrained from

and breast cancer incidence has declined, but not to the levels seen prior t

mammography.[4]

One might expect that if screening identifies cancers before they cause cli

screening will be followed by a period of compensatory decline in cancer r

incidence rates or in incidence rates in older women. However, no compe

ever been seen following the adoption of screening, suggesting that scree

identification of clinically insignificant cancers (refer to the Overdiagnosis

Mammography section of this summary for more information).

Breast cancer incidence and mortality risk also vary according to geograp

socioeconomic status (refer to the Special Populations section of this sum

Risk Factors for Breast Cancer

Breast cancer risk is affected by many factors besides participation in scre

quantifying these risks is important to a woman, to her physicians, and to

Table 1. Risk of Breast Cancer Diagnosisa

Current Age (in Years) Risk in Next 10 Years

30 1 in 250

40 1 in 71

50 1 in 42

http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/Page10#Section_123http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/Page8#Section_402http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/Page8#Section_423http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference2.4http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference2.3http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference2.2http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/Page3#Section_4http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/Page3#Section_66


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ction in the Breast Cancer

cologic studies from the United

d invasive breast cancer incidence

pausal hormone therapy and

sing postmenopausal hormones,

the widespread use of screening

ical symptoms, then the period of

tes, either in annual population

satory drop in incidence rates has

ng leads to overdiagnosis—the

section in the Harms of Screening

y, culture, race, ethnicity, and

ary for more information).

ning activities. Understanding and

public policy makers.

Enlarge

Lifetime Risk of a Breast CancerDiagnosis

1 in 8

1 in 9

1 in 9

http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/Table1http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/Page8#Section_402http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/Page3#Section_4


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a Adapted from Altekruse et al.[2]

70 1 in 27

Age

The incidence of breast cancer increases with a woman's age. As shown in

higher risk of being diagnosed with breast cancer in the next 10 years tha

The cumulative lifetime incidence decreases with advancing age because t

breast cancer diagnosis, the lower her lifetime risk compared to a younger

cancer at a younger or older age. The commonly quoted risk of one in eig

with breast cancer is based on lifetime risk of a diagnosis (not death) start

account for the woman’s current age.[2]

Breast cancer mortality increases with age. For a 40-year-old woman with

chance of dying from breast cancer within the next 10 years is extremely s

65, it is about 1%. For a woman older than 70, the risk of dying of breast c

dying of any cause is higher yet.[5]

Personal history of breast cancer

Women with a personal history of invasive breast cancer, DCIS, or lobulaincreased risk of being diagnosed with a new primary breast cancer.[6] Re

mammograms vary, but evidence for various strategies is scant.

Prior radiation therapy

Women treated with thoracic radiation before the age of 30 years have a 1

starting 8 years after the irradiation and for the rest of their lives.[7,8] An

resonance imaging (MRI) has been proposed in such women, beginning 8

http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference2.8http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference2.7http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference2.6http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference2.5http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference2.2http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference2.2


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years, whichever is later.[9] In a study of screening with mammography a

among 98 asymptomatic women who received a chest radiation dose of 15

cancer. Four of those cancers would not have been detected without the u

multiple screening modalities observed a similar increase in cancer detect

These data suggest that earlier detection is possible with MRI, but do not

adjunct MRI screening.

Dense breast tissue

Women with radiologically dense breasts (heterogeneously dense or extre

the Breast Imaging Reporting and Data System [BI-RADS]) [12-15] haveof breast cancer compared with women who have fatty breasts.[16]

Other risk factors and risk prediction models

Other risk factors for breast cancer include an inherited predisposition ( B

age at menarche and late age at first birth; and previous breast biopsies s

disease.[17-19] Menopausal hormone use, obesity, lack of physical activity

with an increased risk of breast cancer. (Refer to the PDQ summaries on

Breast Cancer Prevention for more information.) Several models estimate

on these and other factors.[20-23]

References

1. American Cancer Society: Cancer Facts and Figures 2014. Atlanta,

Available online. Last accessed May 21, 2014.

2. Altekruse SF, Kosary CL, Krapcho M, et al.: SEER Cancer Statistics

National Cancer Institute, 2010. Also available online. Last accesse

3. Johnson A, Shekhdar J: Breast cancer incidence: what do the figur

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d MRI, 13 cancers were diagnosed

Gy or less for pediatric or adult

e of MRI.[10] Another study of

on with the addition of MRI.[11]

emonstrate a definitive benefit of

ely dense in the terminology of

threefold to sixfold increased risk

CA1 or BRCA2, and others); early

owing benign proliferative breast

and alcohol intake are associated

ancer Prevention Overview and

an individual woman's risk based

a: American Cancer Society, 2014.

Review, 1975-2007. Bethesda, Md:

May 21, 2014.

s mean? J Eval Clin Pract 11 (1): 27-

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4. Haas JS, Kaplan CP, Gerstenberger EP, et al.: Changes in the use of

after the publication of clinical trial results. Ann Intern Med 140 (3

5. Kerlikowske K, Salzmann P, Phillips KA, et al.: Continuing screeni

70 to 79 years: impact on life expectancy and cost-effectiveness. JA

[PUBMED Abstract]

6. Houssami N, Abraham LA, Miglioretti DL, et al.: Accuracy and outin women with a personal history of early-stage breast cancer. JAM

Abstract]

7. Goss PE, Sierra S: Current perspectives on radiation-induced breas


8. Henderson TO, Amsterdam A, Bhatia S, et al.: Systematic review: s

women treated with chest radiation for childhood, adolescent, or y

152 (7): 444-55; W144-54, 2010. [PUBMED Abstract]

9. Saslow D, Boetes C, Burke W, et al.: American Cancer Society guide

as an adjunct to mammography. CA Cancer J Clin 57 (2): 75-89, 20

10. Freitas V, Scaranelo A, Menezes R, et al.: Added cancer yield of bre

screening in women with a prior history of chest radiation therapy.

[PUBMED Abstract]

11. Terenziani M, Casalini P, Scaperrotta G, et al.: Occurrence of breas

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postmenopausal hormone therapy

: 184-8, 2004. [PUBMED Abstract]

g mammography in women aged

A 282 (22): 2156-63, 1999.

omes of screening mammography 305 (8): 790-9, 2011. [PUBMED

cancer. J Clin Oncol 16 (1): 338-

rveillance for breast cancer in

ung adult cancer. Ann Intern Med

ines for breast screening with MRI

7 Mar-Apr. [PUBMED Abstract]

st magnetic resonance imaging

Cancer 119 (3): 495-503, 2013.

cancer after chest wall irradiation

. Int J Radiat Oncol Biol Phys 85

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(1): 35-9, 2013. [PUBMED Abstract]

12. ACR BI-RADS Breast Imaging and Reporting Data System: Breast

Mammography. 4th ed. Reston, Va: American College of Radiology

accessed June 18, 2014.

13. Ma L, Fishell E, Wright B, et al.: Case-control study of factors assoc

cancer by mammography. J Natl Cancer Inst 84 (10): 781-5, 1992.

14. Goodwin PJ, Boyd NF: Mammographic parenchymal pattern and bappraisal of the evidence. Am J Epidemiol 127 (6): 1097-108, 1988.

15. Fajardo LL, Hillman BJ, Frey C: Correlation between breast parenc

mammographers' certainty of diagnosis. Invest Radiol 23 (7): 505-

16. Harvey JA, Bovbjerg VE: Quantitative assessment of mammograph

breast cancer risk. Radiology 230 (1): 29-41, 2004. [PUBMED Abstract]

17. London SJ, Connolly JL, Schnitt SJ, et al.: A prospective study of b

breast cancer. JAMA 267 (7): 941-4, 1992. [PUBMED Abstract]

18. McDivitt RW, Stevens JA, Lee NC, et al.: Histologic types of benign

breast cancer. The Cancer and Steroid Hormone Study Group. Can

Abstract]

19. Jacobs TW, Byrne C, Colditz G, et al.: Radial scars in benign breast-

breast cancer. N Engl J Med 340 (6): 430-6, 1999. [PUBMED Abstract]



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maging Atlas. Vol. 1:

2003. Also available online. Last

ated with failure to detect breast

PUBMED Abstract]

east cancer risk: a critical[PUBMED Abstract]

ymal patterns and

, 1988. [PUBMED Abstract]

c breast density: relationship with

nign breast disease and the risk of

breast disease and the risk for

er 69 (6): 1408-14, 1992. [PUBMED

biopsy specimens and the risk of

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. , , , .

cancer for white females who are being examined annually. J Natl

[PUBMED Abstract]

21. Bondy ML, Lustbader ED, Halabi S, et al.: Validation of a breast ca women with a positive family history. J Natl Cancer Inst 86 (8): 62

22. Spiegelman D, Colditz GA, Hunter D, et al.: Validation of the Gail e

breast cancer risk. J Natl Cancer Inst 86 (8): 600-7, 1994. [PUBMED

23. Amir E, Freedman OC, Seruga B, et al.: Assessing women at high ri

assessment models. J Natl Cancer Inst 102 (10): 680-91, 2010. [PUB

Breast Cancer Diagnosis and Pathology

Evaluation of Breast Symptoms

Women with breast symptoms are not candidates for screening because t

During a 10-year period, 16% of 2,400 women aged 40 to 69 years sought

symptoms at their health maintenance organization.[1] Women younger t

seek evaluation. Additional testing was performed in 66% of these women

performed in 27%. Cancer was diagnosed in 6.2%, most often stage II or I

prompting medical attention, a mass was most likely to lead to a cancer di

likely (1.8%) to do so.

Pathologic Diagnosis of Breast Cancer

Breast cancer is most often diagnosed by pathologic review of a fixed spec

http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference3.1http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=20427433&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8145275&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=2593165&dopt=Abstract


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ancer Inst 81 (24): 1879-86, 1989.

cer risk assessment model in-5, 1994. [PUBMED Abstract]

al. model for predicting individual

bstract]

k of breast cancer: a review of risk

MED Abstract]

ey require a diagnostic evaluation.

medical attention for breast

an 50 years were twice as likely to

including invasive procedures

I. Of the breast symptoms

agnosis (10.7%) and pain was least

men of breast tissue. The breast

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=20427433&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8145275&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8003106&dopt=Abstract


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tissue can be obtained from a symptomatic area or from an area identifie

lesion can be biopsied with core needle biopsy or, less often, fine-needle a

excision; image guidance improves accuracy. Nonpalpable lesions can be

using stereotactic x-ray or ultrasound guidance or can be surgically excise

In a retrospective study of 939 patients with 1,042 mammographically de

needle biopsy or surgical needle localization under x-ray guidance, sensiti

than 95% and the specificity was greater than 90%. Compared with surgic

guidance, core needle biopsy resulted in fewer surgical procedures for def

likelihood of clear surgical margins at the initial excision.[2]

Ductal Carcinoma In Situ

Ductal carcinoma in situ (DCIS) is a noninvasive condition that can evolv

frequency and time course.[3] Some authors include DCIS with invasive b

argue that the term be replaced by ductal intraepithelial neoplasia, simila

cervical and prostate precursor lesions, and that breast cancer statistics e

DCIS is most often diagnosed by mammography. In the United States, on

with DCIS in 1983, compared with approximately 64,000 women who are

when mammographic screening has been widely adopted.[3-5] The Cana

Study-2 of women aged 50 to 59 years found a fourfold increase in DCIS c

breast examination (CBE) plus mammography compared with those scree

difference in breast cancer mortality.[6] (Refer to the PDQ summary on Binformation.)

The natural history of DCIS is poorly understood because nearly all DCIS

retrospective review of 11,760 breast biopsies performed between 1952 an

[7,8] which were detected by physical examination, biopsied without rese

years. Nine women developed invasive breast cancer and four women dieinteresting but probably not relevant to women with screen-detected DCI

http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference3.8http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference3.7http://www.cancer.gov/cancertopics/pdq/treatment/breast/healthprofessionalhttp://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference3.6http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference3.5http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference3.3http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference3.3http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference3.2


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by an imaging test. A palpable

piration biopsy or surgical

ampled by core needle biopsy

after image-guided localization.

ected lesions who underwent core

ity for malignancy was greater

l needle localization under x-ray

nitive treatment, with a higher

to invasive cancer, with variable

east cancer statistics, but others

to the terminology used for

clude these DCIS cases.

y 4,900 women were diagnosed

expected to be diagnosed in 2013,

ian National Breast Screening

ses in women screened by clinical

ned by CBE alone, with no

east Cancer Treatment for more

ases are treated. A single

1968 identified 28 cases of DCIS,

tion, and then followed for 30

of the disease. These findings arein an era of improved cancer care.

http://www.cancer.gov/cancertopics/pdq/treatment/breast/healthprofessional


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Development of breast cancer after treatment of DCIS depends on the cha

the delivered treatment. One large randomized trial found that 13.4% of w

developed ipsilateral invasive breast cancer within 90 months, compared

lumpectomy and radiation.[9] The best evidence indicates that most DCI

cancer and that those that do can still usually be managed successfully, ev

detection and treatment of nonpalpable DCIS often represents overdiagn

Among women diagnosed with (and treated for) DCIS between 1984 and

cancer within 10 years,[10] which was a lower mortality rate than for the

This favorable outcome may reflect the benign nature of the condition, th

volunteer effect (women undergoing breast cancer screening are generally

Attempts to define low-risk DCIS cases that can be managed with fewer t

effort analyzed a series of 706 DCIS patients who were monitored to devel

California/Van Nuys Prognostic Scoring Index, which defines the risk of r

among women with DCIS based on age, margin width, tumor size, and gr

comprising a third of the cases, experienced only 1% DCIS recurrences an

of the use of postoperative radiation therapy. The moderate- and high-ris

rates, and they benefited from postlumpectomy radiation. Overall, only a

cancer. In a separate study, adjuvant tamoxifen therapy was shown to red

cancer.[12]

References

1. Barton MB, Elmore JG, Fletcher SW: Breast symptoms among wo

maintenance organization: frequency, evaluation, and outcome. An

[PUBMED Abstract]

2. White RR, Halperin TJ, Olson JA Jr, et al.: Impact of core-needle b

management of mammographic abnormalities. Ann Surg 233 (6): 7

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racteristics of the lesion but also on

omen treated by lumpectomy alone

ith 3.9% of those treated by

lesions will not evolve to invasive

n after that transition. Thus, the

sis and overtreatment.

989, only 1.9% died of breast

ge-matched population at large.

benefits of treatment, or the

healthier than those who do not).

erapies is important. One such

op the University of Southern

current DCIS and invasive cancer

de.[11] The low-risk group,

no invasive cancers, independent

groups had higher recurrence

proximately 1% died of breast

ce the incidence of invasive breast

en enrolled in a health

Intern Med 130 (8): 651-7, 1999.

east biopsy on the surgical


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3. Allegra CJ, Aberle DR, Ganschow P, et al.: National Institutes of He

Conference statement: Diagnosis and Management of Ductal Carci

2009. J Natl Cancer Inst 102 (3): 161-9, 2010. [PUBMED Abstract]

4. American Cancer Society: Cancer Facts and Figures 2013. Atlanta,

Available online. Last accessed January 10, 2014.

5. Virnig BA, Tuttle TM, Shamliyan T, et al.: Ductal carcinoma in situ

incidence, treatment, and outcomes. J Natl Cancer Inst 102 (3): 17

6. Miller AB, To T, Baines CJ, et al.: Canadian National Breast Screeni

randomized trial in women aged 50-59 years. J Natl Cancer Inst 92

7. Page DL, Dupont WD, Rogers LW, et al.: Intraductal carcinoma of

only. Cancer 49 (4): 751-8, 1982. [PUBMED Abstract]

8. Page DL, Dupont WD, Rogers LW, et al.: Continued local recurrenc

diagnosis of low grade ductal carcinoma in situ of the breast treate


9. Fisher B, Dignam J, Wolmark N, et al.: Lumpectomy and radiationintraductal breast cancer: findings from National Surgical Adjuvan

Clin Oncol 16 (2): 441-52, 1998. [PUBMED Abstract]

10. Ernster VL, Barclay J, Kerlikowske K, et al.: Mortality among wom

the breast in the population-based surveillance, epidemiology and

Med 160 (7): 953-8, 2000. [PUBMED Abstract]

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alth State-of-the-Science

oma In Situ September 22-24,

a: American Cancer Society, 2013.

f the breast: a systematic review of

-8, 2010. [PUBMED Abstract]

ng Study-2: 13-year results of a

(18): 1490-9, 2000. [PUBMED Abstract]

he breast: follow-up after biopsy

of carcinoma 15-25 years after a

only by biopsy. Cancer 76 (7):

herapy for the treatment of Breast and Bowel Project B-17. J

n with ductal carcinoma in situ of

nd results program. Arch Intern



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11. Silverstein MJ: The University of Southern California/Van Nuys pr

in situ of the breast. Am J Surg 186 (4): 337-43, 2003. [PUBMED Abstr

12. Fisher B, Dignam J, Wolmark N, et al.: Tamoxifen in treatment of i

Surgical Adjuvant Breast and Bowel Project B-24 randomised contr


Breast Cancer Screening Concepts

Bias

Numerous uncontrolled trials and retrospective series have documented t

diagnose small, early-stage breast cancers, which have a favorable clinical

also show better cancer-related survival in screened versus nonscreened biases may explain that finding:

1. Lead-time bias: Survival time for a cancer found mammographicall

detection and the time when the cancer would have been detected

this time is not included in the survival time of cancers found beca

2. Length bias: Mammography detects a cancer while it is preclinical,Cancers with longer preclinical durations are, by definition, presen

discovery and therefore are more likely to be detected by screening;

growing and to have better prognoses, irrespective of screening.

3. Overdiagnosis bias: An extreme form of length bias; screening may

growing and would never have become manifest clinically in the wo

4. Healthy volunteer bias: The screened population may be the healthconscious women in the general population.



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gnostic index for ductal carcinoma

ct]

traductal breast cancer: National

olled trial. Lancet 353 (9169):

e ability of mammography to

course.[1] Although several trials

omen, a number of important

includes the time between

ecause of clinical symptoms, but

se of symptoms.

nd preclinical durations vary.during more opportunities for

these cancers tend to be slow

find cancers that are very slow

man’s lifetime.

est and/or the most health-

http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference4.1http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=14553846&dopt=Abstract


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Because the extent of these biases is never clear in any particular study, m

controlled trials to assess the benefits of screening. (Refer to the Cancer S

more information.)

Assessment of Performance and Accuracy

Performance benchmarks for screening mammography in the United Stat

Cancer Surveillance Consortium (BCSC) Web site.

Sensitivity

The sensitivity of mammography is the percentage of breast cancers detec

breast cancer is present. Sensitivity depends on tumor size, conspicuity, a

breast tissue density, patient age, timing within the menstrual cycle, over

skill of the radiologist. Overall sensitivity is approximately 79% but is low

with dense breast tissue (see the BCSC Web site).[2-4] Delay in diagnosis

common cause of medical malpractice litigation and half of the cases resu

involve false-negative mammograms.[5]

Specificity and false-positive rate

The specificity of mammography is the likelihood of the test being normal

false-positive rate is the likelihood of the test being abnormal when cance

many false-positive examinations result in unnecessary follow-up examinsubsection on Harms in the Screening With Mammography section of the

for more information.)

Interval cancers

Interval cancers are cancers that are diagnosed in the interval after a nor

before the subsequent screen. Some of these cancers were present at the t

negatives), and others grew rapidly in the interval between mammograph

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st groups rely on randomized

reening Summary Overview for

s are described on the Breast

ed in a given population, when

d hormone sensitivity as well as

ll image quality, and interpretive

r in younger women and in those

f breast cancer is the most

ting in payment to the claimant

when cancer is absent, whereas the

is absent. If specificity is low,

tions and procedures. (Refer to theOverview section of this summary

al screening examination and

me of mammography (false-

and detection. As a general rule,

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interval cancers have characteristics of rapid growth [6,7] and are frequen

discovery/diagnosis.[8]

One study of 576 women with interval cancers reported that interval canc

aged 40 to 49 years. Interval cancers appearing within 12 months of a neg

appear to be related to decreased mammographic sensitivity, attributable

cases. Those appearing within a 24-month interval appear to be related b

sensitivity due to greater breast density in 37.6% and to rapid tumor grow

Another study that compared the characteristics of 279 screen-detected c

cancers found that interval cancers were much more likely to occur in wo be of mucinous or lobular histology; or to have high histologic grade, high

benign features mammographically and/or to lack calcifications. Screen-d

have tubular histology; to be smaller, low stage, and hormone sensitive; a

ductal carcinoma in situ.[6]

References

1. Moody-Ayers SY, Wells CK, Feinstein AR: "Benign" tumors and "ea

screened patients of a natural cohort with breast cancer. Arch Inter

[PUBMED Abstract]

2. Carney PA, Miglioretti DL, Yankaskas BC, et al.: Individual and co

and hormone replacement therapy use on the accuracy of screenin

138 (3): 168-75, 2003. [PUBMED Abstract]

3. Rosenberg RD, Hunt WC, Williamson MR, et al.: Effects of age, bre

replacement therapy on screening mammographic sensitivity and c

183,134 screening mammograms in Albuquerque, New Mexico. Ra[PUBMED Abstract]

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9807581&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12558355&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10789603&dopt=Abstracthttp://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference4.6http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference4.8http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference4.7http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1/AllPages/Print#Reference4.6


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ly of advanced stage at the time of

rs are more prevalent in women

tive screening mammogram

o greater breast density in 68% of

th to decreased mammographic

h in 30.6%.[9]

ncers with those of 150 interval

en younger than 50 years and toproliferative activity, relatively

etected cancers were more likely to

d to have a major component of

ly detection" in mammography-

Med 160 (8): 1109-15, 2000.

bined effects of age, breast density,

mammography. Ann Intern Med

st density, ethnicity, and estrogen

ncer stage at diagnosis: review of

iology 209 (2): 511-8, 1998.



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4. Kerlikowske K, Grady D, Barclay J, et al.: Likelihood ratios for mod

of breast cancer based on age and mammographic interpretation. J

Abstract]

5. Physician Insurers Association of America: Breast Cancer Study. W

Association of America, 1995.

6. Porter PL, El-Bastawissi AY, Mandelson MT, et al.: Breast tumor c

mammographic detection: comparison of interval- and screen-dete(23): 2020-8, 1999. [PUBMED Abstract]

7. Hakama M, Holli K, Isola J, et al.: Aggressiveness of screen-detecte

(8944): 221-4, 1995. [PUBMED Abstract]

8. Tabár L, Faberberg G, Day NE, et al.: What is the optimum intervalexaminations? An analysis based on the latest results of the Swedis

screening trial. Br J Cancer 55 (5): 547-51, 1987. [PUBMED Abstract]

9. Buist DS, Porter PL, Lehman C, et al.: Factors contributing to mam

40-49 years. J Natl Cancer Inst 96 (19): 1432-40, 2004. [PUBMED Abs

Breast Cancer Screening Modalities—Mammography

Mammography Description and Background

Mammography utilizes ionizing radiation to image breast tissue. The exa

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15467032&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=3606947&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=7741862&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10580027&dopt=Abstracthttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8667537&dopt=Abstract


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rn screening mammography. Risk

MA 276 (1): 39-43, 1996. [PUBMED

shington, DC: Physician Insurers

aracteristics as predictors of

ted cancers. J Natl Cancer Inst 91

breast cancers. Lancet 345

between mammographic screening two-county breast cancer

ography failure in women aged

ract]

ination is performed by



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compressing t e reast irm y etween two p ates. Suc compression spre

reduces the amount of radiation needed to image the breast. For routine s

examinations are taken in both mediolateral oblique and craniocaudal pr

breast tissue from the nipple to the pectoral muscle. Radiation exposure i

screening examination. Two-view examinations are associated with a low

examinations because they eliminate concern about abnormalities due to

structures.[1]

Under the Mammography Quality Standards Act (MQSA) enacted by Con

perform mammography must be certified by the U.S. Food and Drug Adm

of standardized training for personnel and a standardized mammographydose.[2] (Refer to the FDA's Web page on Mammography Facility Surveys

Evaluations, and Medical Physicist Qualification Requirement under MQ

Reauthorization Act requires that patients receive a written lay-language

The following Breast Imaging Reporting and Data System (BI-RADS) cate

mammographic results:[3]

0: Incomplete—needs additional image evaluation and/or prior ma

1: Negative.

2: Benign.

3: Probably benign.

4: Suspicious.

5: Highly suggestive of malignancy.

6: Known biopsy—proven malignancy.

About 10% of women screened will be recalled for additional evaluation;

receive a final disposition of normal or benign after a full diagnostic work

mammographic views, ultrasound or both. About 15% of women recalled biopsy. The chance that biopsy will indicate malignant disease differs by

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s out over apping tissues an

reening in the United States,

jections. Both views should include

4 to 24 mSv per standard two-view

r recall rate than are single-view

uperimposition of normal breast

ress in 1992, all U.S. facilities that

inistration (FDA) to ensure the use

technique utilizing a low radiationMammography Equipment

A.) The 1998 MQSA

ummary of mammography results.

gories are used for reporting

mograms for comparison.

ore than 80% of women will

p, which may include additional

ill receive a recommendation forI-RADS classification. Results from

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, -

indicated the following chance of malignancy (invasive or ductal carcino

2, 0%; category 3, 2%; category 4, 30%; or category 5, 97%.[4]

Benefit of Mammography

Randomized controlled trials

Randomized controlled trials (RCTs), with participation by nearly half a

examined the breast cancer mortality rates of women who were offered re

Canadian National Breast Screening Study (NBSS)-2, compared mammo

examination (CBE) with CBE alone; the other eight trials compared scree

CBE to a control consisting of usual care.

The trials differed in design, recruitment of participants, interventions (b

management of the control group, compliance with assignment to screeniof outcomes. Some trials used individual randomization, while others use

cohorts were identified and then offered screening; one trial used nonran

in any given month. Cluster randomization sometimes led to imbalances

control groups. Age differences have been identified in several trials, altho

too small to have a major effect on the trial outcome.[5] In the Edinburgh

correlates with the risk of breast cancer mortality, differed markedly betw groups, so it is difficult, if not impossible, to interpret the results.

Breast cancer mortality is the major outcome parameter for each of these

determine cause of death are critically important. Efforts to reduce bias in

have been made, including the use of a blinded monitoring committee (N

independent data sources, such as national mortality registries (Swedish tattempts could not ensure a lack of knowledge of women’s assignments to

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a in situ): category 0, 13%; category

illion women from four countries,

ular screening. One trial, the

ram plus clinical breast

ing mammogram with or without

th screening and treatment),

g and control groups, and analysis cluster randomization in which

omized allocation by day of birth

etween the intervention and

ugh the differences were probably

Trial, socioeconomic status, which

en the intervention and control

rials, so the methods used to

the attribution of mortality cause

w York) and a linkage to

ials). Unfortunately, thesescreening or control arms.


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Evidence of possible misclassification of breast cancer deaths in the Two-

favor of screening has been analyzed.[6]

There were also differences in the methodology used to analyze the result

Swedish trials were designed to include a single screening mammogram i

correspond with the end of the series of screening mammograms in the st

these trials used an "evaluation" analysis, tallying only the breast cancer d

whose cancer was discovered at or before the last study mammogram. In

in the performance of the end-of-study mammogram, resulting in more ti

group to develop or be diagnosed with breast cancer. Other trials used a "

all deaths attributed to breast cancer, regardless of the time of diagnosis.

meta-analysis of four of the five Swedish trials in response to concerns ab

The accessibility of the data for international audits and verification also

been undertaken only in the Canadian trials. Other trials have been audit

less rigor.[7]

All of these studies are designed to study breast cancer mortality rather th

the infrequency of breast cancer deaths relative to the total number of dea

these trials was examined retrospectively, only the Edinburgh Trial showe

could be attributed to socioeconomic differences. The meta-analysis (follo

trials also showed a small but significant improvement of all-cause mortal

The trials are described in detail in the Appendix of Randomized Controll

Summary of RCTs

Screening for breast cancer does not affect overall mortality, and the abso

mortality is small.

A way to view the potential benefit of breast cancer screening is to estimat

because of early breast cancer detection.[8,9] One author estimated the o

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ounty Trial with possible bias in

of these trials. Four of the five

the control group, timed to

dy group. The initial analysis of

aths that occurred in women

ome of the trials a delay occurred

e for members of the control

ollow-up" analysis, which counts

his type of analysis was used in a

ut the evaluation analyses.[6]

aries, with formal audit having

d to varying degrees, usually with

n all-cause mortality because of

hs. When all-cause mortality in

a significant difference, which

-up methods) of the four Swedish

ty.

d Trials section of this summary.

ute benefit for breast cancer

e the number of lives extended

tcomes of 10,000 women aged 50

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