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Diagnostic evaluation of women with suspected breast cancer
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Diagnostic evaluation of women with suspected breast cancer
All topics are updated as new evidence becomes available and our peer review process is complete.
Literature review current through: Nov 2016. | This topic last updated: Mar 21, 2016.

INTRODUCTION — Approximately 230,480 American women are diagnosed with breast cancer annually, and 39,520 women die from this disease [1]. Global cancer statistics show that breast cancer is the most frequently diagnosed cancer and the leading cause of cancer death among females, accounting for 23 percent of total cancer cases and 14 percent of cancer deaths [2]. Breast cancer is now also the leading cause of cancer death among females in economically developing countries.

Despite increasing incidence rates, annual mortality rates from breast cancer have decreased over the last decade (1.9 percent per year from 2008 to 2012) [3]. The decline has been more pronounced in Caucasian than in African-American women. (See "Factors that modify breast cancer risk in women".)

A significant portion of the decline in mortality is attributable to the impact of screening mammography, which permits diagnosis at an earlier stage of disease [4]. Preinvasive breast cancer (ductal carcinoma in situ, DCIS) now accounts for 25 to 30 percent of all newly diagnosed, mammographically detected breast cancers. (See "Screening for breast cancer: Strategies and recommendations" and "Breast ductal carcinoma in situ: Epidemiology, clinical manifestations, and diagnosis", section on 'Mammographic screening'.)

The majority of breast cancers are diagnosed as a result of an abnormal mammogram, but not all mammographic findings represent cancer. Women who have an abnormal screening mammogram often need further diagnostic evaluation with magnification views, spot compression views and/or targeted ultrasonography to determine the need for tissue sampling or biopsy. Additionally, not all cancers are detectable on mammography. A clinically suspicious mass should also be biopsied, regardless of imaging findings, as about 15 percent of such lesions can be mammographically occult [5]. The goal of the initial biopsy is to obtain sufficient diagnostic material using the least invasive approach and to avoid surgical excision of benign lesions. (See "Breast biopsy".)

This review will discuss the diagnostic evaluation and management of a woman with suspected breast cancer due to either abnormal imaging or physical findings. Initial staging work-up of patients with newly diagnosed breast cancer, the general approach to evaluation of breast masses in women, and breast biopsy techniques are discussed separately. (See "Clinical features, diagnosis, and staging of newly diagnosed breast cancer" and "Clinical manifestations and diagnosis of a palpable breast mass" and "Breast biopsy".)

IMPORTANCE OF MULTIDISCIPLINARY CARE — A suspicion of breast cancer requires that care be coordinated among clinicians in several specialties. An integrated approach with breast imagers and breast surgeons can minimize unnecessary biopsies and expedite diagnosis for the woman who receives a diagnosis of breast cancer. Similarly, once the diagnosis of cancer is made, multidisciplinary coordination among breast and reconstructive surgeons, radiation and medical oncologists, radiologists and pathologists facilitates treatment planning and streamlines patient care [6].

MAMMOGRAMS — The majority of breast cancers are associated with abnormal mammographic findings [7,8]. As an example, in the Breast Cancer Detection Demonstration Project (BCDDP), fewer than 10 percent of cancers were detected solely by physical examination and over 90 percent were identified mammographically [7].

If an abnormality is found at mammographic screening, supplemental mammographic views and possibly ultrasound should be used for further characterization. A variety of mammographic techniques, including spot compression and magnification views (image 1) and varied angled views, may characterize a lesion more precisely prior to making a final recommendation for management. (See "Breast imaging for cancer screening: Mammography and ultrasonography", section on 'Diagnostic mammogram'.)

Some of the most aggressive cancers appear between normal screening mammograms and are therefore termed interval cancers [9]. Younger women may present with large tumors prior to the age at which screening is usually recommended. Accordingly, when women present with a suspicious new mass, diagnostic mammograms should be part of the initial workup, despite young age or having had a negative routine screening mammogram.

Diagnostic mammography is associated with higher sensitivity but lower specificity as compared to screening mammography. In one prospective study of women with signs or symptoms of breast cancer, 15 percent (6279 of 41,427) of diagnostic mammograms were abnormal [5]. The sensitivity and specificity of diagnostic mammograms declined with breast density, younger age, and mammographic examination.

Screening mammography is discussed in detail elsewhere. (See "Screening for breast cancer: Strategies and recommendations", section on 'Screening with mammography'.)

BI-RADS diagnostic categories — The radiologist summarizes the mammographic findings using the American College of Radiology (ACR) BI-RADS (Breast Imaging Reporting and Data System) final diagnostic assessment categories, which indicate the relative likelihood of a normal, benign, or malignant diagnosis [10].

The BI-RADS final assessment categories standardize both the reporting of mammographic findings and the recommendations for further management (ie, routine screening, short interval follow-up, or biopsy). Assessments are either incomplete (category 0) or final assessment categories (categories 1 through 6) as described on the table (table 1) [10].

If a mammogram is assigned category 0, additional evaluation is required for further characterization which may include additional mammographic views and or ultrasound, and rarely, magnetic resonance imaging (MRI). A BI-RADS designation of 4c or 5 should alert the pathologist that a malignant diagnosis is strongly suspected and that further evaluation of the specimen (and possible rebiopsy) is needed if the biopsy is initially interpreted as benign. (See "Breast imaging for cancer screening: Mammography and ultrasonography", section on 'The BI-RADS categories'.)

Mammographic features of breast cancer — There are two general categories of mammographic findings suggestive of a breast cancer: soft tissue masses and clustered microcalcifications.

Soft tissue mass/architectural distortion — The most specific mammographic feature of malignancy is a spiculated soft tissue mass; nearly 90 percent of these lesions represent invasive cancer (image 2).

Approximately one-third of noncalcified cancers appear as spiculated masses, 25 percent as irregularly outlined masses, 25 percent as less specific round, oval or lobulated masses, less than 10 percent as well-defined round, oval, or lobulated masses, and 5 percent as areas of architectural distortion of dense tissue without an obvious mass [11].

The positive predictive value for malignancy of well-defined solid masses identified by ultrasound with benign imaging features is between 0 and 7 percent, and biopsy or short-term (three to six months) follow-up is considered appropriate management [12].

Clustered microcalcifications — Clustered microcalcifications are calcium particles of various size and shape measuring between 0.1 to 1 mm in diameter and numbering more than four to five per cubic centimeter. Microcalcifications are seen in approximately 60 percent of cancers detected mammographically (image 3A-B). Histologically, these represent intraductal calcifications in areas of necrotic tumor (picture 1) or calcifications within mucin-secreting tumors such as the cribriform or micropapillary subtype of intraductal cancer. (See "Pathology of breast cancer".)

Linear branching microcalcifications (image 3A-B), most commonly associated with the comedo histologic subtype, have a higher predictive value for malignancy than do granular (ie, nonlinear irregular calcifications of varying size and shape) microcalcifications, particularly for high grade DCIS. However, breast cancers, including DCIS, more often present with the granular type of calcifications [8]. Calcifications that are not suspicious for malignancy and considered benign include vascular and skin calcifications, rim-like calcifications, large coarse calcifications (image 4), and smooth round or oval calcifications (image 5).

Despite the association of microcalcifications with ductal carcinoma in situ (DCIS), mammographic appearance alone cannot differentiate between purely intraductal and invasive ductal breast cancers; there is no mammographic correlate of basement membrane invasion [13]. One-third of invasive carcinomas are associated with microcalcifications, with or without a soft tissue mass, and 10 percent of intraductal cancers present as a soft tissue mass without microcalcifications [8]. (See "Breast ductal carcinoma in situ: Epidemiology, clinical manifestations, and diagnosis", section on 'Mammography'.)

Thus, mammographic findings such as masses and calcifications can be stratified by suspicion for malignancy, and the BI-RADS 4a, 4b, and 4c categories are helpful in alerting the referring physicians, the pathologists, and surgeons to the underlying risk of malignancy [14]. Low risk calcifications are much more likely to be benign (table 1). (See 'BI-RADS diagnostic categories' above.)

Assessing the extent of disease — Mammographic assessment of the extent of DCIS and early invasive carcinoma begins during diagnostic mammography and continues through the biopsy, specimen management, and the postexcision mammogram [8]. Mammography of both breasts is particularly important in the patient with DCIS or invasive cancer who is considering breast conservation. Preoperative diagnostic mammography can help to define the extent of disease and may identify multifocal or multicentric cancer that could preclude breast conservation or signal a potential difficulty in achieving clear surgical margins. Multifocal disease is usually defined as involvement of several areas within a breast quadrant, probably representing disease along an entire duct. In contrast, multicentric disease involves multiple areas within different quadrants, probably representing involvement of multiple ducts.

Although the extent of mammographic nonlinear branching microcalcifications frequently underestimates the pathologic extent of the malignancy, the discrepancy is less than 2 cm in 80 to 85 percent of cases [15]. Several clusters of microcalcifications separated by normal appearing tissue should not be interpreted as multifocal or multicentric disease. Often, these represent areas of contiguous tumor that is only partially calcified within a ductal-lobule [15,16].

The combination of a mass and associated calcifications often indicates the presence of an extensive intraductal component (EIC). EIC is defined pathologically as DCIS found adjacent to an invasive carcinoma, accounting for more than 25 percent of the volume of disease. This finding can be a predictor for more widespread residual tumor (usually DCIS) following gross excision of the lesion [17]. (See "Breast ductal carcinoma in situ: Epidemiology, clinical manifestations, and diagnosis" and "Breast conserving therapy", section on 'Extensive intraductal component (EIC)'.)

Postoperative mammograms to look for residual calcifications after surgical resection should be considered when the microcalcifications are not clearly or completely documented on the specimen radiograph or when margins are close or positive [18-20]. If a re-excision is to be recommended on the basis of residual calcifications, care should be taken to ensure that the calcifications are associated with malignancy on histopathology and not benign tissue. Multifocal disease is not necessarily a contraindication to breast conservation, but is one of the factors that should be taken into consideration along with breast size relative to the extent of disease on imaging. (See "Breast conserving therapy" and "Breast ductal carcinoma in situ: Epidemiology, clinical manifestations, and diagnosis".)

A significant limitation of mammographic assessment of disease extent is the obscuring of the borders or extent of the primary tumor by dense overlying tissue. Dense breasts can limit the sensitivity of mammography both for detection of breast cancers and for delineating disease extent [21,22]. In this setting, contrast-enhanced breast magnetic resonance imaging (MRI) may complement mammographic staging. If the clinical extent of disease is larger than what can be appreciated by mammography, MRI may be considered. (See 'Breast MRI' below.)

Mammographic assessment of tumor size for the staging of multifocal disease presents a unique dilemma. Most staging classifications require that the largest tumor mass be utilized for T staging, even in cases where multifocal disease is suspected. However, others suggest that the total surface area, volume, or aggregate measurements are a better indicator of prognosis [23-25]. Accurate delineation of the extent of odd-shaped, irregular, or multifocal tumors is important for treatment planning. (See "Tumor node metastasis (TNM) staging classification for breast cancer".)

For invasive cancers that are contiguous to the chest wall and not completely included on mammographic projections, ancillary imaging techniques such as MRI may be necessary to assess posterior tumor extension and pectoralis fascia or muscle involvement if that will determine a change in surgical approach or the use of neoadjuvant therapy [26]. (See 'Assessment of ipsilateral disease with breast MRI' below.)

Significance of intramammary lymph nodes — Intramammary lymph nodes are detected in 1 to 28 percent of patients with breast cancer [27-31]. Benign nodes can often be distinguished from metastatic or infiltrated intramammary lymph nodes by their mammographic or sonographic appearance, but definitive assessment often requires histopathologic study [32]. The presence of intramammary lymph node metastases appears to confer a worse prognosis, both in women who otherwise have stage I breast cancer based upon tumor size and axillary nodal status and in those with stage II disease [27]. Isolated intramammary lymph node metastases are considered to represent stage II disease, even if the axillary nodes are uninvolved. (See "Tumor node metastasis (TNM) staging classification for breast cancer".)

ULTRASONOGRAPHY — Ultrasound can be used to differentiate between solid and cystic breast masses that are palpable or detected mammographically. In addition, ultrasound evaluation of the axilla can be used to detect lymph nodes that are suspicious for axillary metastases. Ultrasound provides guidance for interventional procedures of suspicious areas in the breast or axilla.

Breast ultrasound — Ultrasound (US) examination of the breast is an important diagnostic adjunct to mammography. In patients suspected of having a breast cancer, breast US is most useful in the following circumstances:

To further characterize a mammographically detected mass or an area of architectural distortion. Breast US can help to characterize solid masses as either benign or malignant. In one report, the sensitivity of US for malignancy was 98.4 percent, and the negative predictive value 99.5 percent [33]. Similar results have been reported in other studies [12,34,35]. Similar findings have been noted in subsequent studies [12]. However, US is highly operator-dependent and significant variability in the ability of radiologists to characterize solid breast lesions by US has been reported [36-38]. A benign solid appearance on US should not be used to avoid biopsy of a mammographically or clinically suspicious mass. (See "Breast imaging for cancer screening: Mammography and ultrasonography", section on 'Role of ultrasound'.)

To identify a cystic mass. Simple cysts need no further intervention because the risk of cancer is very low; one series found no malignancies in 223 cysts [39]. Indeterminate cysts can be aspirated under US guidance. The presence of an intracystic mass should prompt a fine needle aspiration (FNA) or core biopsy of the mass. (See "Breast cysts: Clinical manifestations, diagnosis, and management".)

To further characterize a lesion when a mass detected on clinical breast examination cannot be seen clearly on mammogram (often in women with dense breasts).

To determine whether a mammographically suspicious lesion can be visualized and therefore sampled by US-guided biopsy. (See "Breast biopsy".)

To measure and clip a lesion prior to neoadjuvant chemotherapy. For patients who present with large or locally advanced tumors for which neoadjuvant (induction) chemotherapy is considered, careful anatomic localization is critical to ensure that the surgeon can localize the area of tumor after neoadjuvant therapy. Typically, the lesion is measured both clinically and ultrasonographically, and reported in terms of size, the "o'clock" location on the breast surface, and the distance of the lesion from the nipple. The use of radio-opaque clips placed at the time of biopsy to localize the primary tumor in case there is a complete clinical and radiographic response to induction therapy is discussed below. (See "Breast biopsy", section on 'Clip placement'.)

Breast US is often added to the initial diagnostic evaluation for women with a suspected breast cancer if there is a palpable mass or a density is seen on mammogram. The benefit of this approach was suggested in a series of 2020 patients (470 with a palpable mass) who underwent clinical exam, mammography, and breast US [34]. The systematic addition of breast US detected eight additional malignancies, and correctly downgraded 332 cases of suspected malignancy to no suspected malignancy (predominantly cysts or fibroadenoma). Thus, the main benefit of breast US was improved specificity when used in a targeted manner. The sensitivity, specificity, positive and negative predictive values for clinical examination plus mammography plus US were 96.9, 94.8, 39.2, and 99.9 percent, while the corresponding values for clinical examination plus mammography were 91.5, 87, 19.7, and 99.7 percent, respectively.

Axillary ultrasound — For women with clinically suspicious lymph nodes, preoperative axillary US with fine needle aspiration or core biopsy of suspicious areas provides a means to identify patients who have positive nodes. This information may be used to guide future additional surgery, radiation, or systemic therapy. (See "Clinical features, diagnosis, and staging of newly diagnosed breast cancer", section on 'Lymph nodes' and "Diagnosis, staging and the role of sentinel lymph node biopsy in the nodal evaluation of breast cancer", section on 'Indications'.)

BREAST MRI — Nearly all invasive breast carcinomas enhance on gadolinium contrast-enhanced MRI [40-54]. The sensitivity of breast MRI for breast carcinomas is between 88 and 100 percent [48,55-57]. However, a major disadvantage is the limited specificity of MRI due to enhancement of benign breast lesions [40,42,44-48,58-65]. In a meta-analysis of 44 studies evaluating diagnostic breast MRI in patients with breast lesions, pooled specificity was 72 percent [66]. Specificity can be improved, to some extent, by alterations in technique. The technique of breast MRI is discussed elsewhere. However, even using optimal technique, specificity is still insufficient to obviate the need for biopsy confirmation of an MRI abnormality. (See "MRI of the breast and emerging technologies".)

Assessment of ipsilateral disease with breast MRI — MRI is more sensitive than mammography, ultrasound, or physical examination and identifies additional ipsilateral disease in about 16 percent of women with a known breast cancer [13,36,45,49,55,67-71].

Because MRI is so sensitive, it was assumed that preoperative MRI would estimate the extent of disease more accurately than conventional imaging, thereby improving surgical planning (eg, prompting a change to mastectomy when breast conserving therapy had been previously considered [72]) and enabling surgeons to better obtain clean margins in breast conserving surgery.

However, available data has shown that preoperative breast MRI has not improved outcomes, overestimates the extent of disease, and has overall limited value [73-85]:

It was already known from postmastectomy pathology studies that additional sites of tumor are frequently present in the ipsilateral breast [73]. In fact, the entire purpose of RT in women undergoing breast conserving surgery is to eradicate sites of clinically occult disease in the ipsilateral breast. Multiple prospective randomized trials of breast conserving surgery with and without RT have demonstrated that the high risk of in-breast recurrence (40 percent) without RT is reduced to <10 percent with RT [74-79].

There is no evidence that routine use of breast MRI results in fewer positive margins at the time of partial mastectomy or a lower rate of reoperation to achieve clear margins [72,80]. A United Kingdom (UK) randomized trial (COMICE) evaluating the role of breast MRI in 1623 women with newly diagnosed breast cancer showed no difference in the reoperation rate with or without the use of preoperative MRI (18.7 and 19.3 percent respectively) [80,81]. The lack of a difference in reoperation rates could reflect the UK’s low reported re-excision rate of 10 percent in contrast to US institutions where the rates are closer to 25 percent, presumably due to attempts at removing the smallest volume of tissue possible for breast conservation [82]. In addition, many women had mastectomies (27.6 percent in the group randomized to MRI) without pathological verification of disease as not all centers in this trial performed MRI biopsy or localization.

Because of its low specificity, MRI can delay treatment by necessitating additional biopsies [36,72]. In one study, MRI was associated with a significant 22-day delay in definitive treatment [72].

In a review of 1558 consecutive patients with invasive breast cancer and/or noninvasive breast cancer, MRI was not associated with an advantage to lower re-excision rate, improve the rate of breast conservation surgery achievement, or lower recurrence rate [83].

Assessment of contralateral disease with breast MRI — MRI imaging of the contralateral breast identifies a suspicious, clinically occult finding in 9 to 12 percent of women with a unilateral breast cancer, but cannot distinguish between benign and malignant lesions. In general, a synchronous clinically and mammographically inapparent malignancy will be found in 3 to 5 percent of cases, approximately one-half of which are invasive cancer, and the remainder, intraductal cancer [35,50,86-95], and results in about a 12 percent chance of biopsy [35,50,86-93,96].

As an example, in a meta-analysis of 22 studies (3253 women) of women with newly diagnosed breast cancer, the pooled estimate for detecting a suspicious abnormality that was occult on conventional imaging was 9.3 percent [87]. The incremental cancer detection rate with MRI was only 4 percent because more than half of the suspicious abnormalities detected by MRI alone proved to be benign. The summary estimate of positive predictive value was 48 percent. Interestingly, 10 women underwent contralateral mastectomy based upon MRI findings without a preoperative biopsy. Of these, only three had malignancy and the remaining seven were benign. Of the 42 women who underwent prophylactic mastectomy despite a negative MRI, five (12 percent) unexpected malignancies were identified on final pathology.

The clinical significance, especially the survival benefit, of detecting these cancers has not been addressed. As is the case with MRI of the affected breast, the finding of a contralateral malignancy on breast MRI may lead to overtreatment. Many of these subclinical cancers are effectively treated with the systemic therapy used for the treatment of the initial cancer. As an example, in the Early Breast Cancer Trialists Collaborative Group (EBCTCG) overview analysis, the incidence of contralateral breast cancer was reduced by 50 percent in patients receiving five years of adjuvant tamoxifen, and by 20 percent in patients receiving adjuvant chemotherapy [97].

Finally, the detection of these contralateral cancers must be weighed against the added time and additional costs associated with MRI and MRI-guided biopsy. Of MRI-detected lesions recommended for biopsy, only about one in five prove to be malignant [98]. The available data do not show that detection rates or clinical utility differs in any subset of breast pattern (including dense breasts) or histologic type (DCIS, ductal or lobular carcinoma) [15,32,34,36,99]. (See "Breast ductal carcinoma in situ: Epidemiology, clinical manifestations, and diagnosis", section on 'Role of magnetic resonance imaging'.)

For all of these reasons, the role of MRI to assess the contralateral breast is controversial and cannot be routinely recommended for the majority of women with a newly diagnosed breast cancer.

There are some clinical scenarios where breast MRI might be considered prior to therapy to assess contralateral disease.

High risk women — A contralateral breast MRI is reasonable for women with newly diagnosed breast cancer who are considered at very high risk for contralateral breast cancer based on the following criteria:

The patient is a known carrier of a breast cancer gene mutation in BRCA 1 or BRCA 2 (hereditary breast and ovarian cancer syndrome). (See "Genetic counseling and testing for hereditary breast and ovarian cancer".)f

The patient is a first-degree relative of a known BRCA 1 or BRCA 2 mutation carrier.

The patient has an estimated lifetime risk of breast cancer of 20 percent or higher, as estimated using the BRCA-PRO model, used to identify women for breast cancer genetic testing [100]. (See "Risk prediction models for breast cancer screening", section on 'Clinical use of risk prediction models'.)

The patient was previously treated with radiation to the chest wall (eg, for Hodgkin lymphoma). (See "Second malignancies after treatment of classical Hodgkin lymphoma", section on 'Breast cancer'.)

The patient has a personal history or a first-degree relative with Li-Fraumeni syndrome or one of the PTEN hamartoma tumor syndromes such as Cowden syndrome. (See "Overview of hereditary breast and ovarian cancer syndromes" and "Li-Fraumeni syndrome" and "PTEN hamartoma tumor syndrome, including Cowden syndrome".)

Issues related to breast reconstruction — Some surgeons prefer a preoperative MRI to assess the opposite breast in a woman undergoing significant reconstructive procedures such as a partial mastectomy with contralateral breast reduction or mastectomy with flap reconstruction:

An abdominal flap can only be raised once, and the reconstructive technique used might differ if bilateral reconstruction rather than unilateral reconstruction is planned.

When a contralateral reduction is planned as part of the reconstructive process, MRI of the contralateral breast may avoid unexpected disease, particularly if there is a condition that will make mammographic screening less sensitive, such as dense breasts.

Effect of tumor histology on MRI — Tumor histology does not appear to be a predictor for the utility of breast MRI. Although some studies have reported that MRI accurately determines disease extent for invasive lobular cancers, which are often associated with only subtle mammographic changes, this is not uniformly the case [15,32,34,36,99].

Although early studies reported difficulty in detecting ductal carcinomas in situ (DCIS) on MRI, subsequent studies suggest that MRI can accurately determine the extent of high grade DCIS, with sensitivities of 89 to 94 percent [36,50,101]. MRI detection of DCIS has been shown to improve with experience [102].

Effect of MRI on mastectomy rates — A number of studies have reported that MRI results in changes in surgical management and may be a factor in the increased use of mastectomy and bilateral mastectomy in women with newly diagnosed breast cancers [36,50-52,69,95,103,104]. As an example, in a population of 3606 women with newly diagnosed breast cancer, women who underwent MRI were twice as likely to have contralateral prophylactic mastectomy performed [88].

Effect of MRI on recurrence and survival rates — An unresolved question is whether the routine use of MRI to detect multifocal or multicentric disease results in fewer local recurrences and better long-term survival [37,38]. In a retrospective review of 756 patients treated for newly diagnosed breast cancer, 215 patients had breast MRI as part of their initial evaluation, and 541 did not [105]. The eight-year rates of any local failure or local-only first failure were 3 and 4 percent with and without MRI, respectively, and rates were similar in women who had invasive or intraductal cancers. Furthermore, there were also no differences in eight-year rates of overall or cause-specific survival.

Guidelines for the use of preoperative breast MRI — The use of breast MRI in the preoperative evaluation of a newly diagnosed breast cancer has increased significantly over the last ten years, largely due to the high sensitivity for detecting otherwise occult breast cancer in the affected and contralateral breasts. Advocates of MRI cite as potential benefits an improvement in the selection of patients for breast conserving surgery, a decrease in the number of surgical procedures needed to obtain clear margins, and the synchronous detection of contralateral cancers. However, there are no data from prospective randomized trials that demonstrate improved outcomes from the addition of breast MRI to the diagnostic evaluation of newly diagnosed breast cancer. Furthermore, because of limited specificity, the use of breast MRI increases unnecessary surgery, delays definitive treatment, and may lead to overtreatment.

Routine preoperative MRI is not indicated for the majority of patients with early stage breast cancer. In keeping with consensus-based guidelines from the National Comprehensive Cancer Network (NCCN) and the available data, we and others consider the role of breast MRI in the evaluation of women with newly diagnosed breast cancer as follows [20,83,94,98,106-108]:

The evaluation of a woman with a newly diagnosed breast cancer in whom the clinical extent of disease is larger than what is appreciated by mammography (particularly in the setting of dense breasts which lower the sensitivity of mammography). (See 'Assessing the extent of disease' above.)

For invasive cancers that are contiguous to the chest wall and not completely included on mammographic projections, MRI may be necessary to assess posterior tumor extension and pectoralis fascia or muscle involvement if that will determine a change in surgical approach or the use of neoadjuvant therapy [26]. (See 'Assessing the extent of disease' above.)

For patients with axillary nodal metastases and a clinically occult primary tumor, breast MRI can facilitate the identification of occult breast cancer and help select patients most likely to benefit from surgery. (See "Axillary node metastases with occult primary breast cancer", section on 'Breast MRI'.)

For women with Paget’s disease of the breast who have a negative physical examination and mammogram, breast MRI can define the extent of disease and aid in treatment planning [109,110]. (See "Paget disease of the breast", section on 'Magnetic resonance imaging'.)

In women with locally advanced breast cancer who are being considered for upfront (neoadjuvant) systemic therapy, breast MRI may be used to define the extent of disease, and potential for breast conserving therapy. However, following neoadjuvant therapy, breast MRI can overestimate residual invasive cancer, and is not accurate for predicting pathologic response. Methods for monitoring the response to neoadjuvant systemic therapy in locally advanced breast cancer are discussed in detail elsewhere. (See "General principles of neoadjuvant therapy for breast cancer", section on 'On-treatment evaluation' and "General principles of neoadjuvant therapy for breast cancer", section on 'Clinical assessment and indications for imaging'.)

For women with very high risk for contralateral disease (for example, because of an inherited predisposing condition, or prior chest wall irradiation). (See 'High risk women' above.)

For women who are planning extensive reconstructive surgery, breast MRI may be used to identify occult contralateral cancers. (See 'Issues related to breast reconstruction' above.)

Women should be informed of the risks and benefits of preoperative breast MRI. The limits of the accuracy of MRI should be discussed with patients, so that they understand the need for biopsy of MRI detected lesions before definitive surgery. Breast MRI should be performed with a dedicated breast coil by expert breast imaging radiologists in institutions that have the capability to perform MRI guided needle biopsy and/or wire localization of the findings.

Surgical decisions should not be based on MRI findings alone. MRI findings alone should not be used to change surgical planning and conversion from breast conservation to mastectomy. All suspicious findings on MRI require pathologic confirmation.

DIAGNOSTIC ALGORITHMS — There is significant variability in the diagnostic evaluation of women with suspected breast cancer. Patterns of referral vary dramatically, as do rates of screening mammography recall. The work-up and evaluation may differ, depending upon which clinician is seen first. Diagnostic algorithms are helpful as general guidelines, but they must be adapted to include patient preferences.

Mammographic abnormalities — The figure (algorithm 1) describes an algorithmic approach to the evaluation of a mammographic abnormality, which integrates BI-RADS assessment categories (table 1).

Women with palpable masses — Algorithms for clinical and imaging evaluation of palpable masses are stratified by the age of the woman. Even in the setting of palpable masses, image guidance may improve diagnostic accuracy. A clinically suspicious mass should be biopsied regardless of imaging findings, as 10 to 15 percent of such lesions can be mammographically occult [9].

Younger women — The diagnostic approach to the evaluation of palpable masses in younger women differs among experts.

The approach that is advocated by the National Comprehensive Cancer Network (NCCN) is an initial breast US (algorithm 2 and algorithm 3) [20]. If the examination is indeterminate or suspicious, mammography is often performed, although its utility in young women with breast masses or nodularity is limited [111], and a biopsy is probably warranted even if the mammogram is negative. If the mass cannot be visualized by US, mammography may be considered, or alternatively, a tissue biopsy or period of observation may be appropriate depending upon the level of clinical suspicion. (See "Clinical manifestations and diagnosis of a palpable breast mass" and "Breast biopsy".)

Alternatively, aspiration can be selected as an initial approach to a breast mass in a younger woman (algorithm 2) [20]. If no fluid is aspirated and cytologic review of cell blocks from the needle washings are nondiagnostic, then US is performed. If the capacity to perform or interpret FNA is limited at an institution, this approach is not optimal. (See "Breast biopsy".)

If the initial evaluation shows cancer, bilateral breast imaging should be performed promptly and prior to any definitive surgery to exclude unsuspected or more extensive disease.

Older women — If a palpable mass is appreciated, bilateral diagnostic mammography should be performed prior to biopsy, even if the mass is clinically suspicious for cancer (algorithm 3 and algorithm 4) [20]. Fine needle aspiration or core needle biopsy may alter both mammographic or US appearance. The goal of imaging in this setting is not to establish a diagnosis of cancer, but rather to identify other suspicious areas or calcifications in either breast that might impact treatment. This evaluation should be performed prior to percutaneous biopsy, so that biopsy of additional suspicious lesions can be undertaken at one time. If the lesion is large and breast conservation is not an option, this is less important. (See "Breast biopsy".)

BIOPSY — In the patient with a suspicious mammographic abnormality or palpable breast mass, the obligatory diagnostic technique is biopsy. Surgical biopsy should not be utilized as a diagnostic tool unless percutaneous palpation-guided or image-guided biopsy is not feasible [112,113]. A preoperative histologic diagnosis of invasive carcinoma may allow the surgeon to plan a single operation to treat the cancer, including sentinel lymph node biopsy or full axillary dissection, depending upon the clinical circumstances. Excision of more extensive areas of DCIS may also be optimally planned if the diagnosis has been established by percutaneous core needle biopsy. (See "Breast biopsy".)

It is important to note that a needle biopsy may cause hematoma and inflammation at the site of the mass and enlargement of the axillary nodes, which can make clinical assessment and surgical planning more difficult. Physical exam changes from needle biopsy often resolve by the time of surgery. If the palpable lesion is small or subtle, it is helpful to arrange wire localization of the clip placed at the time of biopsy to facilitate breast conserving surgery. (See "Breast conserving therapy".)

SUMMARY AND RECOMMENDATIONS

The majority of breast cancers are diagnosed as a result of an abnormal mammogram, but the majority of mammographic findings represent benign tissue. (See 'Introduction' above.)

A clinically suspicious mass should be biopsied, regardless of imaging findings, as 10 to 15 percent of such lesions can be mammographically occult. (See 'Introduction' above.)

Women who have an abnormal screening mammogram need further diagnostic evaluation with magnification views, spot compression views and/or targeted ultrasonography to determine the need for tissue sampling or biopsy. (See 'Introduction' above.)

The American College of Radiology (ACR) BI-RADS (Breast Imaging Reporting and Data System) final diagnostic assessment categories indicate the relative likelihood of a normal, benign, or malignant diagnosis and standardize both the reporting of mammographic findings and the recommendations for further management. (See 'BI-RADS diagnostic categories' above.)

While intervention is recommended for all BI-RADS category 4 lesions, the probability of malignancy can be stratified as low, intermediate and moderate to high in subclassifications of BI-RADS 4 as 4a, b, or c. The use of these subclassifications provides a useful estimate of the risk that a suspicious lesion will prove to be malignant.

Ultrasound (US) examination of the breast is an important diagnostic adjunct to mammography and is used to differentiate between solid and cystic masses and to provide guidance for interventional procedures. (See 'Breast ultrasound' above.)

Breast MRI is highly sensitive, and can identify foci of cancer that are not evident on physical examination, mammogram, or ultrasound. Although advocates of MRI cite as potential benefits improved selection of patients for breast conserving surgery, a decrease in the number of surgical procedures needed to obtain clear margins, and the synchronous detection of contralateral cancers, there are no data from prospective randomized trials that demonstrate improved outcomes from the addition of breast MRI to the diagnostic evaluation of newly diagnosed breast cancer. Furthermore, because of limited specificity, the use of breast MRI increases the number of unnecessary biopsies, delays definitive treatment, and increases the number of patients undergoing mastectomy. As a result, breast MRI is not recommended as a routine component of the diagnostic evaluation of breast cancer for most women. (See 'Breast MRI' above.)

We and others consider the role of breast MRI in the evaluation of women with newly diagnosed breast cancer in the following circumstances. (See 'Guidelines for the use of preoperative breast MRI' above.)

For patients with axillary nodal metastases and a clinically occult primary tumor.

When the clinical extent of disease is larger than what is appreciated by mammography (particularly in the setting of dense breasts which lower the sensitivity of mammography).

To assess posterior tumor extension and pectoralis fascia or muscle involvement if that will determine a change in surgical approach or the use of neoadjuvant therapy.

For women with Paget’s disease of the breast who have a negative physical examination and mammogram.

In women with locally advanced breast cancer who are being considered for upfront (neoadjuvant) systemic therapy.

For women with very high risk for contralateral disease (for example, because of an inherited predisposing condition, or prior chest wall irradiation) or those who are undergoing a prophylactic contralateral mastectomy.

For women who are planning extensive reconstructive surgery (eg, rectus abdominus myocutaneous flap), breast MRI may be used to identify occult contralateral cancers.

Suspicious lesions seen on MRI must be biopsied to confirm diagnosis before planning definitive surgery. (See 'Breast MRI' above.)

Diagnostic algorithms can provide useful guidelines for the work up of a suspicious finding on breast imaging or breast examination. (See 'Diagnostic algorithms' above.)

In the patient with a suspicious mammographic abnormality or palpable breast mass, the obligatory diagnostic technique is biopsy. Surgical biopsy should not be utilized as a diagnostic tool unless percutaneous palpation-guided or image-guided biopsy is not feasible. (See 'Biopsy' above.)

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