Karen M. Freund, MD, MPH
Despite the advances in breast imaging, there are clear indications for the need of clinical breast examination as part of breast cancer screening for all women. The article reviews the technique for clinical breast examination and assessment of its results. The main goal of the clinical breast examination is to differentiate normal physiologic nodularity from a discrete breast mass. If a discrete mass is identified, evaluation is mandatory in all cases to exclude breast cancer. This evaluation is guided by the features of the clinical findings, the age of the woman, and her personal risk for breast cancer.
The rapid expansion of new technologies in screening and early detection of breast cancer would seem to diminish the value of clinical breast examination. Certainly, we have improved technology and demonstrated the benefits of mammography in early breast cancer detection,[1-6] and new technologies, including computed tomography and magnetic resonance imaging, are in development. New markers for mutations in the BRCA1 and BRCA2 genes have enabled stratification of certain high-risk women. Despite these advances, there continues to be a real need for expertise in clinical breast examination.
This article will outline the rationale for this need and review the data on the technique of clinical breast examination and the management of women with abnormal clinical findings.
Despite the improvements in technology, early detection of breast cancer is not always straightforward. Mammography at its best has a sensitivity of about 85% to 90% in women older than 50 years of age; for women between the ages of 40 and 50, sensitivity is about 75% and is probably lower in women younger than age 40. This means that mammography will miss 1 in every 4 breast cancers in women between the ages of 40 and 50. Clinical breast examination is required to address these gaps in screening sensitivity.
Second, false-positive results can occur with mammography. That is, an abnormality found on screening examination may later be determined to be either an artifact of the technique or a benign finding. With annual screening over 10 years, the chances of a false-positive result, depending on the lesion and a woman's risk, may be over 50%. Given the controversy around the efficacy of mammography before age 50 and this high potential for a false-positive result, some patients, and some providers, are electing to wait to begin mammography screening until the patient is 50 years old. This underscores the need for clinical breast examination.
Skill in conducting and interpreting clinical breast examination findings is essential, especially in the context of a mammogram without abnormalities. The most common reason for litigation for failure to diagnose breast cancer occurs in the setting of a young woman with a finding on clinical or self breast examination and a negative mammogram. Most practicing physicians, when surveyed, acknowledge a need to increase their competence in clinical breast examination.
Lastly, with the increasing use of mammography, there is evidence that providers are more likely to omit the clinical breast examination, perhaps because they believe that the mammographic examination is sufficient.[14,15] In addition, some studies have shown that rates of clinical breast examination decrease with patient age, as a woman's risk increases.
Physicians trained in internal medicine and family medicine perform clinical breast examination at lower rates than gynecologists, although most women older than age 40 seek their primary care from providers within these 2 specialties. These data underscore the need for these providers to conduct clinical breast examinations in their female patients.
Clinical Breast Examination Technique
There are 3 specific components of the clinical breast examination that have been systematically evaluated and found to influence the accuracy of the examination.[18,19] These are the amount of time spent on the examination, the search pattern utilized, and the finger technique in palpation.[20,21]
Time spent on clinical breast examination is one of the best predictors of sensitivity. Several studies have shown that spending 2 minutes on the breast examination improves sensitivity.[20,21] Although 1 study reported that 5- to 10-minute examinations further improve sensitivity, this was conducted in the context of a research protocol. I do not believe this is necessary, or even desirable, for screening examinations, and this length of time could be potentially distressing to a patient. Even 2 minutes can seem like a long time for examination.
Describing the findings to patients and reviewing technique for self breast examination while conducting the clinical breast examination provide women with needed health education and feedback to understand what the clinician is evaluating during the length of the examination. In addition, one of the most common reasons women cite for failure to perform self breast examination is their inability to interpret physiologic nodularity. Patient education during the clinical breast examination may improve adherence to the self breast examination.
The second critical aspect of the clinical breast examination technique is the search pattern used to detect abnormalities. Studies have documented that a systematic search pattern that ensures that all breast tissue is examined is essential for increasing the sensitivity of the clinical breast examination. With the patient supine during the examination, her hands above her head, the area for examination should extend from the clavicle, medially to the midsternum, laterally to the midaxillary line, and to the inferior portion of the breast. In addition, the examination should include the axillary tail of breast tissue and the axilla to search for palpable lymphadenopathy. One should be aware that the breast tissue is not evenly distributed across the chest. Rather, 50% of the breast tissue is located in the upper outer quadrant, and 20% is located under the nipple areolar complex 23]
Most breast tissue is seen in upper outer quadrant.
Three search patterns are commonly described (Figure 2). The first is the radial spoke method -- wedges of tissue are examined beginning at the periphery toward the nipple in a radial pattern. The second is the concentric circle method -- the breast is examined in larger or smaller concentric circles. These methods share similar limitations. Often the tissue under the nipple-areolar complex is omitted, thus as much as 20% of breast tissue goes unexamined. Second, these 2 patterns are more likely to skip areas of tissue during the examination.
A third search pattern, often called the vertical strip pattern, has been compared directly with the 2 patterns in the examination of silicone breast models and has been shown to increase sensitivity of the examination.[22,24,25] This pattern examines the breast tissue in overlapping vertical strips across the chest wall. The vertical strip method is probably superior for ensuring that all breast tissue is examined, because the examiner is better able to track which areas have been examined, and the entire nipple-areolar complex is included.
The third critical aspect of the clinical breast examination is the finger technique. Again, systematic studies using both patients and silicone breast models have shown that the superior technique entails the use of the pads of the 2nd, 3rd, and 4th fingers held together, making dime-sized circles. The finger pads begin in each circle using light pressure, then repeat in the same area with medium and deep pressure before moving to the next area for examination.
Observations of students indicate that failure to apply deep pressure limits the sensitivity of the examination in detecting deeper lesions.
Most descriptions of the breast examination provide a detailed set of maneuvers with the patient in the sitting as well as lying position -- for inspection of visual abnormalities, such as skin puckering or dimpling, which would indicate a lesion affixed to other structures. There is no systematic data to verify the added value of these procedures, which significantly extend the time of a screening examination.[19,26] My clinical experience has been that nearly all abnormalities that are identified with visual inspection through maneuvers are also identified visually or by palpation during the supine examination. Although this more detailed examination may be warranted for diagnostic evaluation when the patient presents with a breast complaint, I do not believe that it is necessary for a standard screening examination.
Given the limited time primary providers have to address so many facets of the patient's health, I believe that the time is best spent focused on the examination using the palpation techniques described. During palpation, visual inspection for skin abnormalities and nipple asymmetry should be conducted. Nipple expression for discharge is unnecessary and should not be performed. Previous work has demonstrated that while spontaneous discharge with hemorrhage is associated with benign and malignant lesions, expressed discharged is not.
Predictive Value of the Clinical Breast Examination
The sensitivity of clinical breast examination has been evaluated in clinical trials in terms of the benefits in comparison to mammography. The sensitivity of clinical breast examination (48% to 69%) is lower than that associated with mammography (75% to 90%). Of import, however is that clinical breast examination is able to identify the 10% to 25% of breast cancers that are missed by mammography.[9,28] The specificity of the clinical breast examination is 85% to 99%. The predictive value of the clinical breast examination is the major limitation, because the examination alone cannot differentiate malignant from benign palpable lesions, and therefore all lesions must be considered and evaluated as malignant. Of the lesions detected by the clinical breast examination, only 6% to 46% are malignant, depending on the age of the patient.
The additional testing to exclude malignancy in women is a limitation of the clinical breast examination, as it is with all screening modalities currently available. The effects of false-positive results have been documented in terms of emotional distress and decreased plans for future screening. However, given the low cost to women already being seen for other health issues and examinations, the clinical breast examination probably remains a cost-effective strategy.
When is a Lump a Lump?
The normal physiology of breast tissue is one of nodularity. The variation in tissue is in part determined by menstrual phase of the cycle, with increased nodularity in the luteal phase of the cycle resulting from engorgement of vessels and stromal tissue. However, the variation in nodularity of breast tissue among both premenopausal and postmenopausal women is considerable and must be recognized.
The most difficult aspect of the clinical breast examination is deciding whether to consider an area a part of the normal physiologic nodularity or a dominant mass. When conducting the clinical examination, I first describe the overall texture of the breast tissue and specific areas of increased density or nodularity. After describing the underlying texture of the breast tissue, I then question whether there is an area that would be described as discrete or dominant within the underlying nodularity.
The discrete mass should be carefully described in terms of location, size, mobility, and texture. When it remains in doubt whether a palpable finding is discrete or part of physiologic nodularity, repeat examination during the follicular phase of the next menstrual cycle or second opinion from another colleague is warranted.
Management of the Patient With Lumpy Breasts
Physiologic nodularity, often referred to (incorrectly) as fibrocystic breast disease, is in fact physiologic. Therefore, the issue is not one of treatment. Rather, it is how to follow patients with dense and nodular breast tissue so as to maintain high sensitivity without sacrificing specificity in the clinical breast examination.
Documenting the areas of nodularity is critical to follow differences in the examination over time. Reexamination during the follicular phase can often clarify findings in premenopausal women.
Although data have not conclusively shown any benefit of caffeine elimination, some isolated small studies have shown that a caffeine-free diet can reduce clinically palpable breast findings. Repeating the examination several months after a decrease in caffeine consumption can provide additional reassurance of the benign nature of clinically palpable findings if they can be documented to be decreasing in size.
Lack of adherence to self breast examination is in part related to anxiety because of this nodularity.
Reviewing the finding of nodularity provides women with information and reassurance about what they are finding on their own, which will be of value for their own examinations. For patients with normal breast cancer risk, annual examination is recommended. For women with extensive nodularity on clinical breast examination and who have a high risk of breast cancer, examinations every 6 months may be of benefit in detecting new findings, although this has not been studied.
Management of the Patient With a Discrete Mass
If a discrete mass is felt, the evaluation must demonstrate that this is not a breast cancer. Fortunately, most lesions are not malignant, and many benign lesions can be adequately assessed without the need for an excisional biopsy.
Algorithm for addressing a breast mass.
A. Algorithm 1 - Management of a breast lump in a woman younger than 35 years of age. B. Algorithm 2 - Management of a breast lump in a woman 35 years of age or older.
The diagnostic evaluation is always guided by the clinical findings on the breast examination. Hard -- or fixed -- masses, masses associated with skin inflammation or induration (often called peau d'orange), and masses larger than 1.5-2.0 cm require excisional biopsy for diagnosis. In some cases, a needle biopsy can be performed as a less invasive step to establish a breast cancer diagnosis. However, the absence of tumor cells from a needle biopsy in a suspicious mass requires full excision to exclude cancer.
The decision to proceed to open biopsy is also dictated by the results of risk assessment of the patient. For older women and women with a first-degree relative with breast cancer, who are at higher risk for cancer, excisional biopsy may be indicated even for lesions that have benign characteristics on examination.[32,33]
Evaluation of Women 35 Years of Age and Younger
The diagnostic evaluation of a breast mass is determined in part by the patient age, because mammography in women younger than age 35 is unlikely to identify multifocal or contralateral disease. Also, because of the known lack of sensitivity of mammography in women younger than age 35, only 50% of lesions or fewer are likely to be identified. Therefore, the decision making is unlikely to be affected by the results of mammography; in most cases, mammography is not indicated.
For women younger than 35 years, there are 2 approaches to evaluation of the mass with benign features based on available technology and patient preference. One option is to perform fine needle aspiration on the palpable mass. If the lesion is found to be fluid filled, it is confirmed to be a cyst and aspirated. Most authors argue against fluid analysis for what is most likely a simple cyst in a young woman. The patient is then followed at 3- to 6-month intervals to ensure the cyst does not recur. If the lesion is found to be solid, a fine needle aspiration biopsy (FNAB) is completed, and material from the needle is sent for cytologic confirmation. A lesion with an adequate specimen and benign cytopathology can be followed, as data suggest that the likelihood of a malignancy in the face of benign clinical and cytologic features is extremely low.[23,34] Any change over time, including growth, should be reason to excise the cyst, even with previous benign cytopathology.
The alternative approach is to begin with ultrasound. Ultrasound is not useful as a screening test, and ultrasound of the breast tissue without a specific indication is likely to identify areas of possible discrete abnormality whose significance is uncertain. However, ultrasound is very effective in differentiating a cystic lesion from solid tissue. If the ultrasound identifies a simple cyst, without internal echoes and with good through transmission, observation in 3-6 months can be recommended, and many cysts will spontaneously resolve.
Ultrasound cannot reliably differentiate between normal tissue and benign or malignant lesions. Therefore, if the ultrasound does not identify a simple cyst, tissue analysis from FNAB or excisional biopsy is indicated.
Evaluation of Women Older Than 35 Years of Age
The evaluation of women older than age 35 begins with mammography. Mammography is used in part to determine whether any malignant characteristics are present in the palpable mass. Mammography at this point is also used to look for multifocal nonpalpable disease in the ipsilateral breast as well as nonpalpable contralateral disease. However, even if the lesion in question is not identified on mammography, or is determined to have benign features, further evaluation is mandatory.
Ultrasound of a benign-appearing/feeling lesion can be conducted to assess the possibility that the lesion is a simple cyst.
Cysts are considered physiologic in response to hormone cycles in premenopausal women and therefore benign. Because hormonal cycles have ceased in postmenopausal women, it is believed that all cysts are nonphysiologic and warrant further evaluation. My experience is that most cysts in postmenopausal women occur in those on estrogen with or without progestin treatment. Women who develop a cyst while on hormone replacement therapy (HRT) can develop more in the future. Therefore, strategies for managing postmenopausal women on HRT with a new simple cyst are to consider (1) aspiration of the first cyst but not subsequent cysts if they appear simple on ultrasound, (2) careful follow-up without aspiration, or (3) consideration of the indications for HRT, and temporary or permanent discontinuation of that therapeutic modality. If the ultrasound does not demonstrate a simple cyst, biopsy is indicated.
Solid lesions require tissue diagnosis. Differentiation of low-grade malignant lesions with fine needle biopsy can occasionally be difficult. Therefore, many clinicians believe that either core biopsy or excisional biopsy should be employed in this group at increased risk because of age.
There is a continuing need for physicians to become and remain proficient in the clinical breast examination. While technological advances have improved on the limited sensitivity and specificity of the clinical breast examination in the early detection of breast cancer, they have not eliminated the need for this part of the physical examination. All primary care providers in internal medicine, family medicine, and obstetrics and gynecology should include the clinical breast examination as part of their routine examination.
Ann's NOTE: In October, 2003 I heard Joann G. Elmore, Section Head, Division of General Internal Medicine; Adjunct Professor, Epidemiology, Univ of Washington School of Medicine, Seattle, WA speak on Clinical Breast Exam.
She stated that a good exam would take about 15 minutes per breast. She joked that women would feel confused by such a long examination and wonder what was going on. But on a serious note, she pointed out that since most clinical breast exams are done by Gyns or Primary care physicians, a 30 minute examination of breasts was unlikely.
Studies show most people spend just 7-12 minutes face to face with their doctors.
REMEMBER: Always remind your doctor about your personal situation. They do not recall your facts like you do. They usually have NOT reread your chart as they pick it up as they enter the exam room.
From Canadian Breast Cancer Network
Int'l J of Health Services, 2001
Breast Self-Exams by Teenagers
Canadian Medical J 1/02
Cancer Causes and Control, 6/01
Cancer Nursing, 2/02
European Journal of Surgical Oncology, 4/02
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